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Product Strategy Consultants for Dietary Supplements

by NaturPro in Uncategorized Comments: 0

Product strategy for health products like supplements requires extensive knowledge of consumer trends, marketing, consumer behavior, food science, regulatory requirements and technical and scientific affairs.

NaturPro Scientific combines expertise in a wide array of product types and disciplines, offering clients a way to maximize chances for consumer product success in the market.

Product Strategy – Cores of Discipline 

A product may be determined as safe and effective, and also legal and kosher — but still not be positioned for success.  For example, it may be undifferentiated in a crowded market, or not provide a meaningful benefit that is valued by the consumer. A great product may find itself swimming in infested waters filled with competitors.

 Our in-depth analysis and advisory process helps to guide our clients in the right direction.

Some main considerations for any supplement product design consultants includes the following:

  1. Target Health Category(s) and subcategories, including potential niche markets
  2. Market Opportunity Analysis
  3. Market Size & Market Leaders
  4. Key Competitor Analysis
  5. Pricing Sensitivity
  6. Consumer Preference Analysis, including consumner surveys and focus groups
  7. Key Product Benefit
  8. Regulatory Review
  9. Customer Demographics
  10. Differentiation, Positioning and Competitive Analysis
  11. Innovation Strategy
  12. SWOT Analaysis
  13. Marketing and Distribution Channel Analysis

Customized Private Label Dietary Supplements

by Morgan Settle in Uncategorized Comments: 0

As Private Label Formulators we often get asked what we think of a product concept. The thought process to develop an answer is generally similar, regardless of the type of dietary supplement, and whether its finished product, or an ingredient or raw material.

A number of considerations go into formulating successful, effective, safe and compliant dietary supplements, foods, and food and dietary ingredients.  These include:

  • What does the supplement or food do?
  • What can be claimed about the product?
  • Is the evidence supporting the claims sufficient?
  • How safe is the product?
  • Who will benefit from the product?
  • How is the ingredient dosage determined?
  • Are the ingredients available at an acceptable quality, cost and volume?


The 4 Steps to Private Label Dietary Supplement Formulation

There are 4 basic elements to formulating a groundbreaking private label dietary supplement:

  1. Begin with the finished product in mind. Determine in full detail how the product will be marketed, what the desired product claims will be, and how the product will address an unmet market need.
  2. Intimately understand the product value and market positioning compared to the competition. How will the product address an unmet need, or be different than what is already found on the market?  How will the product be priced compared to the competition? A full competitive analysis is important to determine positioning.
  3. What language will be used to describe the product? (This language, found on product labels and on webpages, is considered to be part of product claims.)
  4. In what country(s) will the product be marketed?  Regulations in different countries vary, and it is important to understand the unique requirements of each location.

It is the result of preparation, hard work, and learning from failure. -Colin Powell


Private label formulating plans often coordinate the knowledge of dietary supplement consultants and experts, review regulatory status of the product and evaluate the available scientific evidence.  A good formulating plan will identify not only opportunities, but also gaps and risks that may prevent success.

Contact us for more information on our Dietary Supplement Formulation and Development

Additional Reading:

Food and Supplement Claims with Confidence

Dietary Supplement Formula Development

Dietary Supplement Ingredient Regulatory Status

Supplement Manufacturing Consulting

Creating Natural Product Intellectual Property

Healthy Food and Beverage Formulators

by Morgan Settle in Uncategorized Comments: 0

Creating a successful healthy food or beverage is a lot more than selecting a list of ingredients that mix well together.

NaturPro has a broad base of knowledge in product development and production of dietary supplements, healthy foods and healthy beverages, spanning from raw material to finished functional food or beverage.

We guide our clients in the right direction, by helping to manage all or parts of the process for healthy food and beverage formulation and development — from seed to shelf — for dietary supplement and health food products.

Functional Food and Drink Development

Our client list includes folks of all shapes and sizes, from startup to large corporation.

No two clients or products are the same, but there are some common approaches found in our Product Development Toolbox:

Product Development Toolbox: Top 5 Product Development Tools:

Product development requires a ‘toolbox’ of analysis including the following

  1. Market Analysis, Competitive Analysis and Positioning
  2. Regulatory Status / Safety Assessment
  3. Claims Development and Substantiation
  4. Product Costing and Financials
  5. Ingredient Readiness, Supplier Qualification

Contact Us

Private Label Drink and Beverage Powder Supplement Formulation

by Morgan Settle in Uncategorized Comments: 0

Creating a successful customized drink and beverage powder is a lot more than creating a list of ingredients that mix well together.

NaturPro has a broad base of knowledge in production of drinks and beverage powder development, spanning from pilots to private labels.

We guide our clients in the right direction, by helping to manage all or parts of the process for private label drink and beverage powder formulation and development all for dietary supplement and health products.

Drink and Beverage Supplement Formula Development

Our client list includes folks of all shapes and sizes, from startup to large corporation.

No two clients or projects are the same, but there are some common approaches found in our Development Toolbox:

Powder Development Toolbox: Top 10 Powder Development Tools:

Powder development requires a ‘toolbox’ of analysis including the following

  1. Market Analysis, Competitive Analysis and Positioning
  2. Regulatory Status / Safety Assessment
  3. Claims Development and Substantiation
  4. Powder Costing and Financials
  5. Ingredient Readiness, Supplier Qualification
  6. GMP’s, Specifications, and Analytical Testing
  7. Intellectual Property Development
  8. Manufacturing Feasibility
  9. Contract Manufacturer Qualification and Negotiation 

Contact Us

Pilot and Benchtop Prototype Capsules for Dietary Supplements

by Morgan Settle in Uncategorized Comments: 0

Creating a successful pilot and bench top prototype capsule is a lot more than creating a list of ingredients that mix well together.

NaturPro has a broad base of knowledge in capsule development and prototype formulation as well as healthy foods and natural products, spanning from raw material to finished consumer product.

We guide our clients in the right direction, by helping to manage all or parts of the process for natural product formulation and development — from seed to shelf — for dietary supplement and health food products.

Prototype Capsule Formulation

Our client list includes folks of all shapes and sizes, from startup to large corporation.

No two clients or projects are the same, but there are some common approaches found in our Development Toolbox:

Capsule Development Toolbox: Top 10 Capsule Development Tools:

Product development requires a ‘toolbox’ of analysis including the following

  1. Market Analysis, Competitive Analysis and Positioning
  2. Regulatory Status / Safety Assessment
  3. Claims Development and Substantiation
  4. Costing and Financials
  5. Ingredient Readiness, Supplier Qualification
  6. GMP’s, Specifications, and Analytical Testing
  7. Intellectual Property Development
  8. Manufacturing Feasibility
  9. Contract Manufacturer Qualification and Negotiation 

Contact Us

Dietary Supplement Formulation

by Morgan Settle in Uncategorized Comments: 0

As Dietary Supplement Formulators we often get asked what we think of a product concept. The thought process to develop an answer is generally similar, regardless of the type of product, and whether its finished product, or an ingredient or raw material.

A number of considerations go into formulating successful, effective, safe and compliant dietary supplements, foods, and food and dietary ingredients.  These include:

  • What does the supplement or food do?
  • What can be claimed about the product?
  • Is the evidence supporting the claims sufficient?
  • How safe is the product?
  • Who will benefit from the product?
  • How is the ingredient dosage determined?
  • Are the ingredients available at an acceptable quality, cost and volume?


The 4 Steps to Dietary Supplement Formulation

There are seven basic elements to formulating a groundbreaking product:

  1. Begin with the finished product in mind. Determine in full detail how the product will be marketed, what the desired product claims will be, and how the product will address an unmet market need.
  2. Intimately understand the product value and market positioning compared to the competition. How will the product address an unmet need, or be different than what is already found on the market?  How will the product be priced compared to the competition? A full competitive analysis is important to determine positioning.
  3. What language will be used to describe the product? (This language, found on product labels and on webpages, is considered to be part of product claims.)
  4. In what country(s) will the product be marketed?  Regulations in different countries vary, and it is important to understand the unique requirements of each location.

Sufficient time spent in the planning phase is the difference between success and failure.


Product formulating plans often coordinate the knowledge of supplement consultants and experts, review regulatory status of the product and evaluate the available scientific evidence.  A good formulating plan will identify not only opportunities, but also gaps and risks that may prevent success.

Contact us for more information on our Dietary Supplement Formulation and Development

Additional Reading:

Food and Supplement Claims with Confidence

Dietary Supplement Formula Development

Dietary Supplement Ingredient Regulatory Status

Supplement Manufacturing Consulting

Creating Natural Product Intellectual Property

QC Testing Consultants for Supplements and Foods

by NaturPro in Uncategorized Comments: 0

We are QC Testing Consultants for Supplements and Foods.

NaturPro offers independent quality control analysis and testing for foods and dietary supplements.

Why Testing is Important: Supplement and natural product testing with a compliant laboratory is required by FDA for foods, dietary supplements and ingredients to ensure they meet standards for safety, quality and effectiveness.

For example, identity, potency and purity are quality control parameters needed to legally sell a natural product as an ingredient, food or dietary supplement.

Have food or supplement testing questions? Contact Us..

NaturPro Scientific is driven to achieve the right answers for our clients.  Some have even called us the UnLab. Why?

Being independent means that we do not own or have interest in any laboratory, which means we are free to pick from the top scientific experts for each type of test or analysis. 

As a result, we are truly able to work on behalf of our clients, to ensure that correct methods are used and results are obtained.


Natural Product and Supplement Testing Consultants
Food and Supplement Testing Consultants

Objectives of QC Testing:

  1. To ensure analytical methods used are valid and fit for purpose
  2. To make sure laboratories don’t take shortcuts with your sample
  3. To determine if results are precise and accurate
  4. To replicate the results of another lab
  5. To resolve out-of-specification test results
  6. To resolve disputes in data reports
  7. To determine if “dry-labbing” may be occurring
  8. To have an independent expert to review methods and results
  9. To perform due diligence on a supplier or partner
  10. To eliminate the potential for perceived conflict of interest when testing own products
  11. To qualify a lab as a good partnership choice.

3 main benefits of food and dietary supplement QC testing consultants:

  1. Better analysis and testing validity  for reliable, replicable and defensible results.
  2. Fast turnaround and lower testing costs.
  3. Reduced retesting, rejections, production delays and product recalls.

We know the shortcuts that testing labs can take, and how to prevent that from happening to you, to ensure testing gives the most scientific, accurate and defensible results possible.


Contact Us with your QC Testing Questions


Adaptogens adapt to current substantiation needs

Western research is adapting its study endpoints and designs to better understand the benefits of adaptogenic herbs. 

Blake Ebersole | Mar 01, 2019

Adaptogens are an idea whose time has come, and their story has been developing for millions of years. Life on Earth has always required organisms to adapt to their environments to survive and reproduce.

It’s generally accepted that various forms of stress negatively impact health, and that reducing stress can help support a person’s well-being. In the broadest sense, stress can manifest in many ways—on physical, emotional and mental levels—down to the systemic, cellular and molecular levels. Fatigue, anxiety and depression are symptoms related to poor regulation of neurotransmitters; metabolism and related pathways all are either symptoms, causes or mitigating factors of stress and compromised health.

In a world where every nutrition and health idea draws controversy, most agree that foods can reduce stress. Not many Twitter or Facebook arguments contend that chocolate and wine don’t relieve stress.

Yet, the term “adaptogenic” is not widely accepted in the medical or scientific lexicon. The term has been hidden in the scientific literature after its coining by 1960s-era Russian researchers studying herbs including Rhodiola rosea and Eleutherococcus senticosus (eleuthero). Adaptogens were originally defined as “substances that increase resistance to a broad spectrum of harmful factors (stressors) of different physical, chemical and biological natures.”1 More recently, the definition has adapted to include “metabolic regulators, which increase the ability of an organism to adapt to environmental factors.”

One challenge to the mainstream acceptance of adaptogens in the West is their roots in Eastern philosophy. The cyclical nature of life, and the central ideas of homeostasis, often conflict with a predominant Western version of rational, reductionist thought that seeks to apply linear thinking to nonlinear problems, jamming various shapes of pegs into a specific size of square hole like a stubborn 2-year-old.

Adaptogenic activity is not confined to a single pathway, but involves subtle interactions with multiple biochemical pathways. Adaptogenic foods and herbs are not single-compound drugs, but are complex mixtures of hundreds or thousands of potentially bioactive compounds that together work in ways impossible to fully understand. Adaptogens work differently in different people at different times. As a result, the effects of adaptogens are often difficult to study and prove using typical clinical trial designs considered “gold standard” in Western-based drug research.

The Western scientific process is limited by several factors, including its objective to produce a simple pass/fail answer based on statistical probability (a.k.a., P<0.05) and the limitations of currently available measurement tools. The use and acceptance of adaptogens in the West is fraught with this conflict. It seems that the only way to make sense is to adapt and adopt the best of both East and West.

Across the spectrum of traditional use and modern scientific research, adaptogenic herbs such as rhodiola, eleuthero, ginseng (both Asian and American species), ashwagandha, astragalus, holy basil and bacopa have shown positive, repeatable effects—even in multiple forms, with effects repeated by multiple research groups. Looking broader, anti-inflammatory and antioxidant ingredients like docosahexaenoic acid (DHA), turmeric and plant polyphenols have displayed an ability to support the body’s resistance to oxidative and cellular stress, which often manifest as improving the body’s resilience to stress.

Preclinical studies have repeatedly found that treatments with adaptogenic properties (which in addition to herbs and foods, also includes many drugs like antidepressants and anti-inflammatories) alter the “tipping point” where adaptive processes turn maladaptive in the presence of stress. In the presence of stressors, adaptogens often exhibit neuroprotective, anti-fatigue, anti-depressant, immunosupportive, anxiolytic and central nervous system (CNS) stimulant activity.2 Many studies have found adaptogenic foods and herbs to exert a balancing effect on neurotransmitter receptors, including serotonin and dopamine, which may be central to their effects.1

Adaptogens are shown to support the regulation of homeostasis by acting on the hypothalamic-pituitary-adrenal (HPA) axis and regulating key mediators of stress response, such as heat shock protein, stress-activated JNK1, neuropeptide Y, antioxidant enzymes, and nitric oxide.2 Many adaptogens are associated with genetic mediating effects and longevity signaling pathways. Beyond mechanism of action, adaptogens are known to impact clinical endpoints related to cognitive function, the immune system and physical performance.

It stands to reason that natural products supported by a long history of safe and traditional use, particularly today as part of products formulated by scientists and medical experts, which are validated in well-designed, randomized, controlled human clinical trials, should be accepted within the set of options available for people to build resistance to stress.

Even the most Westernized of medical practices have begun to offer stress-relieving services like meditation and aromatherapy. It is common sense for anyone who has witnessed the efficacy of herbs to relax and recover.

In the face of the actual evidence, the “evidence-based” mongers, who disregard anything that’s not proven in the same way as a modern drug, appear as brazenly ignorant.

Luckily, research efforts have greatly accelerated in places like Europe, India and China, where thousands of peer-reviewed study publications overwhelmingly support the ability of numerous natural products and foods to support the body’s ability to adapt and resist the effects of stress.

While mainstream medicine is still reluctant about adaptogens, many peer-reviewed academic journals listed on the National Institutes of Health (NIH) database (Medline) accept the term “adaptogenic” as a primary descriptor for these types of natural products—372 published studies, based on a recent search.

Rhodiola, or “golden root,” considered by many to be the “true original” adaptogen, has been the subject of several recent studies. Two 2018 studies illustrated the effects of rhodiola on burnout3 and neuronal plasticity4 in humans.

These studies illustrate opportunities for clinical researchers to advance their design for studying adaptogens based on evolving knowledge. One of the lessons is to include enough of the right kind of subjects—including populations who are not simply selected at random, but whose medical history, lifestyles and baseline characteristics are better understood and controlled within the study.

Another lesson applied in recent research is the adoption of more sensitive and relevant clinical endpoints in real-world settings. The evolution of virtual clinical trials (VCTs) using observational study designs and modern technology (like wearables) may provide better ways to study and substantiate the effects of adaptogens.

It’s likely that future research on adaptogens will learn from past lessons. Because as science has revealed, we need to adapt to new knowledge, including the fact that there exist many other shapes of pegs than square.

Blake Ebersole has led several botanical quality initiatives and formed collaborations with dozens of universities and research centers. As president of NaturPro Scientific , Ebersole established quality compliance and product development services for supplements and ingredients such as ID Verified™. Follow him on Twitter at @NaturalBlake.

This article was first published in Natural Products Insider, March 2019

References:

1. Panossian A. “Understanding adaptogenic activity: specificity of the pharmacological action of adaptogens and other phytochemicals.” Ann N Y Acad Sci. 2017 Aug;1401(1):49-64. DOI: 10.1111/nyas.13399.

2. Panossian A, Seo E, Efferth T. “Novel molecular mechanisms for the adaptogenic effects of herbal extracts on isolated brain cells using systems biology.” Phytomedicine. 2018 Nov 15;50:257-284. DOI: 10.1016/j.phymed.2018.09.204.

3. Ross S. “Burnout: A Multicenter Exploratory Clinical Trial With a Proprietary Extract of Rhodiola rosea in Patients With Burnout Syndrome.” Holist Nurs Pract. 2018 Nov/Dec;32(6):336-339. DOi: 10.1097/HNP.0000000000000299.

4. Concerto C et al. “Exploring the effect of adaptogenic Rhodiola Rosea extract on neuroplasticity in humans.” Complement Ther Med. 2018 Dec;41:141-146. DOI: 10.1016/j.ctim.2018.09.013.

Cannabis Consultants

by NaturPro in Uncategorized Comments: 0

NaturPro Scientific stands out as consultants who work for our clients.

Our history: We have more than 30 years experience in developing the scientific aspects of botanical products to support human health. So when we started to work on cannabis, hemp and CBD products in 2013, it was second nature.

There are a lot of things to consider when developing cannabis products or hiring a consultant.

  1. Whether your partners understand regulations, compliance and quality assurance, and how to balance these with business. We help you meet the legal requirements and regulations, without breaking the bank.
  2. Scientific expertise and experience across all the function platforms of health product businesses. Whether it’s the science, regulations, communications, validation or due diligence needed, you need someone who’s going to share expert opinions with honesty and transparency.
  3. Inside knowledge of industry standards through active participation on committees of industry standards-setting organizations like American Herbal Products Association, ASTM International and the U.S. Hemp Roundtable. We have a solid reputation in the food, supplement, CBD and cannabis  industry as someone you can trust.
  4. Experience consulting and working efficiently with companies of all sizes and types. Our clients ultimately value our knowledge of both the ideal and the practical, and helping to bridge the gap between efficiently and cost effectively.

Contact us today to learn more about how our expert consultants can help drive your cannabis firm and products to groundbreaking innovation, compliance and success.

——————-

Cannabis Consultants and Experts in Innovation, Product Development and Regulatory Compliance

——————-

Quick Links:

——————–

 

NaturPro Scientific is a recognized leader in regulatory compliance, GMP and quality assurance on CBD, cannabis, botanical drugs, dietary supplements and foods.

What are Good Manufacturing Practices?  Good Manufacturing Practices (GMP) ensures products are consistently produced and controlled to the quality standards and conform to all applicable regulatory requirements.  Good Manufacturing Practices are fundamental to any manufacturing industry and are often required to be implemented in plants and factories by national governments.  Our team of experts can assist you with the development and evaluation of GMP programs  for cannabis, marijuana, hemp and CBD products.

We help you to train qualified staff, get in-depth and correct understanding of standards, and establish comprehensive management systems.

Audits for GMP and Quality Assurance

Here are some of the services we offer for cannabis compliance:

  • Audits
    • Preliminary Gap Analysis
    • Facility GMP pre-audits
    • Internal Audits
    • Third-Party Audits
    • CAPA Audits
  • Quality Management
  • Materials Testing
  • Process Approvals
  • Documentation and SOP
    1. Quality Manual
    2. Recordkeeping
    3. Document Control
    4. Traceability & Recall
      1. Formula Records
      2. Batch Records
      3. Certificates of Analysis
    5. Risk Analysis
      1. Hazard Analysis
      2. Purchasing Criteria & Specifications
    6. Supplier Qualification
    7. Preventive Controls
    8. Product Approval & Rejection, Material Inspection
    9. Complaints & CAPA (Corrective Actions)
    10. Quality Issue Investigation and Resolution
  • Training and Hiring
  • Investor Due Diligence

cannabis-consultants-extraction-GMP

NaturPro Scientific are cannabis consultants for extraction and GMP

NaturPro works closely with our clients to provide the most cost effective way to achieve GMP certification and an edge in the market.

The 4 main benefits of our audits (among many) include:

  1. Understanding where you are may not meet regulatory requirements
  2. Provide reviews and recommendations from a fresh perspective
  3. Train your staff on dealing with regulatory audits
  4. Reduce the risk of a food safety issue or costly product recall.

Audits are an integral part of the licensing and ongoing regulatory compliance process for cannabis, marijuana and CBD products. Cannabis audits can be rigorous, and are seen as a true ‘stress test’ on your quality system.

Pre-License Audits
Prior to issuing a license (e.g.,  Cultivation, Processor, Retail), regulators may require demonstration  compliance with the relevant cannabis regulation, and to ensure implementation of critical regulatory requirements such as physical security requirements, recordkeeping and good production practices. Licensed cannabis firms are required to demonstrate regulatory compliance at these audits in order to achieve (and maintain) their license.

Introductory Audits

An introductory audit may be scheduled after the pre-licensing audit, when the licensee is ready to start production. NaturPro Scientific is often hired to participate in and support our clients before, during and after regulatory audits. This audit is conducted to verify compliance against regulations in addition to inventory control/activities.

GMP Audit 
This type of audit assesses compliance against established Good Manufacturing Process (GMP) guidelines. Our experts have extensive experience with GMP audits to assist cultivators and processors  identify gaps against the regulations/standards, and putting appropriate corrective and preventative actions in place.

Quality Assurance
NaturPro has FDA-trained food safety experts (PCQI) and chemists on staff, and we are often called to perform duties of a Quality Manager for our clients. We handle and interpret lab testing, support supply chain and supplier qualification based on best practices for cannabis and botanical drugs.

 

Standard operating procedures (SOP) for cultivation, processing and testing operations can be challenging. NaturPro Scientific’s experience with SOP helps you get to your desired outcome quickly and efficiently.

Our experience in cannabis includes:

  • Currently serve on ASTM International and American Herbal Products Association (AHPA) Cannabis Committees
  • Supported the development of operating standards and wrote standard operating procedures (SOP) for Good Manufacturing Practices (GMP) for cannabis standards‐setting organization, currently under review by ASTM International
  • Currently serve as regulatory and quality assurance consultant for hemp industry and trade organizations
  • Founding member of new self regulatory organization for hemp and CBD products
  • Coordinated initial R&D, production, quality assurance and regulatory affairs for a cannabis startup with operations in Washington, Colorado and Nevada
  • Assisted in development of cannabis license applications in New York, Florida, California, Colorado and Louisiana
  • Established analytical testing standards and guidelines for potency and purity of cannabis products
  • Audited cannabis analytical laboratory data according to ISO 17025 standards
  • Developed in‐house formulas, materials lists, manufacturing processes, manufacturing records and operational guidelines for cannabis extract and finished product production
  • Developed R&D for and commercial processes for large‐scale extraction and purification of cannabinoids and terpenes from cannabis

CBD Procedures and SOP (Standard Operating Procedures) are the central part of operations of any cultivation, extraction, processing, packaging or testing business. Startups who invest in solid standard operating procedures (SOP) find themselves several steps ahead, running efficiently, with well-trained staff, and don’t suffer any costly mistakes.

CBD SOP are required by each state where cannabis, marijuana or hemp are regulated.

Any cannabis, hemp, medical or adult-use (recreational) marijuana product is subject to a number of controls, from seed to shelf. NaturPro Scientific has supported a number of clients in the aim of providing safe, effective cannabis and hemp products to support human health.


  1. Cultivation or Processing
    1. Management
    2. Applicable Regulations
    3. Operations
    4. Training & Safety
    5. Hygiene
    6. Sanitation & Cleaning
    7. Farm or Facility
    8. Equipment
    9. Seeds and Propagation Materials
    10. Agricultural Inputs
    11. Pre-harvest practices
    12. Harvesting
    13. Post-harvest practices
    14. Drying & Milling
    15. Sampling
    16. Testing (Potency, purity, cannabinoids, microbiology, heavy metals, pesticides)
    17. Waste Management
  2. Quality Management Systems
    1. Product Quality Policy/Manual
    2. Recordkeeping
      1. Document Control
      2. Formula Records
      3. Batch Records
      4. Certificates of Analysis
    3. Traceability & Recall
    4. Risk Analysis
      1. Hazard Analysis
      2. Purchasing Criteria & Specifications
      3. Supplier Qualification
      4. Intentional Adulteration
      5. Preventive Controls
    5. Product Approval & Rejection, Material Inspection
    6. Complaints & CAPA (Corrective Actions)



CBD Quality Consultants and Experts 

by NaturPro in Uncategorized Comments: 0

In a world where everyone claims to be an expert, NaturPro Scientific stands out as consultants who work for our clients.

Our history: We have more than 30 years experience in developing the scientific aspects of botanical products to support human health. So when we started to work on cannabis, hemp and CBD products in 2013, it was second nature.

Our experience: There are a lot of things to consider when developing cannabis products or hiring a consultant.

First, is whether your partners understand regulations, compliance and quality assurance, and how to balance these with business. We help you meet the legal requirements and regulations, without breaking the bank.

Second, is scientific expertise and experience across all the function platforms of health product businesses. Whether it’s the science, regulations, communications, validation or due diligence needed, you need someone who’s going to share expert opinions with honesty and transparency.

Third, is inside knowledge of industry standards through active participation on committees of industry standards-setting organizations like American Herbal Products Association, ASTM International and the U.S. Hemp Roundtable. We have a solid reputation in the food, supplement, CBD and cannabis  industry as someone you can trust.

Fourth — is experience consulting and working efficiently with companies of all sizes and types. Our clients ultimately value our knowledge of both the ideal and the practical, and helping to bridge the gap between efficiently and cost effectively.

Contact us today to learn more about how our expert consultants can help drive your cannabis firm and products to groundbreaking innovation, compliance and success.

——————-

CBD Quality Consultants and Experts Specializing in Innovation and Product Development and Regulatory Compliance

——————-

Quick Links:

——————–

 

NaturPro Scientific is a recognized leader in audits, GMP and quality assurance on CBD, cannabis, botanical drugs, dietary supplements and foods.

What are Good Manufacturing Practices?  Good Manufacturing Practices (GMP) ensures products are consistently produced and controlled to the quality standards and conform to all applicable regulatory requirements.  Good Manufacturing Practices are fundamental to any manufacturing industry and are often required to be implemented in plants and factories by national governments.  Our team of experts can assist you with the development and evaluation of GMP programs  for cannabis, marijuana, hemp and CBD products.

We help you to train qualified staff, get in-depth and correct understanding of standards, and establish comprehensive management systems.

CBD Auditors, GMP and Quality Assurance

Here are some of the services we offer for cannabis compliance:

  • Audits
    • Preliminary Gap Analysis
    • Facility GMP pre-audits
    • Internal Audits
    • Third-Party Audits
    • CAPA Audits
  • Quality Management
  • Materials Testing
  • Process Approvals
  • Documentation and SOP
    1. Quality Manual
    2. Recordkeeping
    3. Document Control
    4. Traceability & Recall
      1. Formula Records
      2. Batch Records
      3. Certificates of Analysis
    5. Risk Analysis
      1. Hazard Analysis
      2. Purchasing Criteria & Specifications
    6. Supplier Qualification
    7. Preventive Controls
    8. Product Approval & Rejection, Material Inspection
    9. Complaints & CAPA (Corrective Actions)
    10. Quality Issue Investigation and Resolution
  • Training and Hiring
  • Investor Due Diligence

cannabis-consultants-extraction-GMP

NaturPro Scientific are cannabis consultants for extraction and GMP

NaturPro works closely with our clients to provide the most cost effective way to achieve GMP certification and an edge in the market.

The 4 main benefits of our audits (among many) include:

  1. Understanding where you are may not meet regulatory requirements
  2. Provide reviews and recommendations from a fresh perspective
  3. Train your staff on dealing with regulatory audits
  4. Reduce the risk of a food safety issue or costly product recall.

Audits are an integral part of the licensing and ongoing regulatory compliance process for cannabis, marijuana and CBD products. Cannabis audits can be rigorous, and are seen as a true ‘stress test’ on your quality system.

Pre-License Audits
Prior to issuing a license (e.g.,  Cultivation, Processor, Retail), regulators may require demonstration  compliance with the relevant cannabis regulation, and to ensure implementation of critical regulatory requirements such as physical security requirements, recordkeeping and good production practices. Licensed cannabis firms are required to demonstrate regulatory compliance at these audits in order to achieve (and maintain) their license.

Introductory Audits

An introductory audit may be scheduled after the pre-licensing audit, when the licensee is ready to start production. NaturPro Scientific is often hired to participate in and support our clients before, during and after regulatory audits. This audit is conducted to verify compliance against regulations in addition to inventory control/activities.

GMP Audit 
This type of audit assesses compliance against established Good Manufacturing Process (GMP) guidelines. Our experts have extensive experience with GMP audits to assist cultivators and processors  identify gaps against the regulations/standards, and putting appropriate corrective and preventative actions in place.

Quality Assurance
NaturPro has FDA-trained food safety experts (PCQI) and chemists on staff, and we are often called to perform duties of a Quality Manager for our clients. We handle and interpret lab testing, support supply chain and supplier qualification based on best practices for cannabis and botanical drugs.

 

Standard operating procedures (SOP) for CBD processing operations can be challenging. NaturPro Scientific’s experience with SOP helps you get to your desired outcome quickly and efficiently.

Our experience in cannabis includes:

  • Currently serve on ASTM International and American Herbal Products Association (AHPA) Cannabis Committees
  • Supported the development of operating standards and wrote standard operating procedures (SOP) for Good Manufacturing Practices (GMP) for cannabis standards‐setting organization, currently under review by ASTM International
  • Currently serve as regulatory and quality assurance consultant for hemp industry and trade organizations
  • Founding member of new self regulatory organization for hemp and CBD products
  • Coordinated initial R&D, production, quality assurance and regulatory affairs for a cannabis startup with operations in Washington, Colorado and Nevada
  • Assisted in development of cannabis license applications in New York, Florida, California, Colorado and Louisiana
  • Established analytical testing standards and guidelines for potency and purity of cannabis products
  • Audited cannabis analytical laboratory data according to ISO 17025 standards
  • Developed in‐house formulas, materials lists, manufacturing processes, manufacturing records and operational guidelines for cannabis extract and finished product production
  • Developed R&D for and commercial processes for large‐scale extraction and purification of cannabinoids and terpenes from cannabis

CBD Procedures and SOP (Standard Operating Procedures) are the central part of operations of any cultivation, extraction, processing, packaging or testing business. Startups who invest in solid standard operating procedures (SOP) find themselves several steps ahead, running efficiently, with well-trained staff, and don’t suffer any costly mistakes.

CBD SOP are required by each state where cannabis, marijuana or hemp are regulated.

Any cannabis, hemp, medical or adult-use (recreational) marijuana product is subject to a number of controls, from seed to shelf. NaturPro Scientific has supported a number of clients in the aim of providing safe, effective cannabis and hemp products to support human health.


  1. Cultivation or Processing
    1. Management
    2. Applicable Regulations
    3. Operations
    4. Training & Safety
    5. Hygiene
    6. Sanitation & Cleaning
    7. Farm or Facility
    8. Equipment
    9. Seeds and Propagation Materials
    10. Agricultural Inputs
    11. Pre-harvest practices
    12. Harvesting
    13. Post-harvest practices
    14. Drying & Milling
    15. Sampling
    16. Testing (Potency, purity, cannabinoids, microbiology, heavy metals, pesticides)
    17. Waste Management
  2. Quality Management Systems
    1. Product Quality Policy/Manual
    2. Recordkeeping
      1. Document Control
      2. Formula Records
      3. Batch Records
      4. Certificates of Analysis
    3. Traceability & Recall
    4. Risk Analysis
      1. Hazard Analysis
      2. Purchasing Criteria & Specifications
      3. Supplier Qualification
      4. Intentional Adulteration
      5. Preventive Controls
    5. Product Approval & Rejection, Material Inspection
    6. Complaints & CAPA (Corrective Actions)