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Dietary Supplement Regulatory and Compliance Consultants

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NaturPro is known for customized quality and compliance solutions, including:

Regulatory and Compliance

Dietary Supplement Regulatory Compliance Consultants

NaturPro Scientific are Dietary Supplement Regulatory Compliance Consultants

  • Conduct Audits (paper and in-person)
    • Compliance & Preparatory Audits
      • Good Agricultural and Collection Practices (GAP/GACP)
      • Good Manufacturing Practices (GMP) (21 CFR 117, 111)
      • Good Laboratory Practices (GLP) (ISO 17025)
      • Organic (NOP)
      • Non-GMO (NGP)
    • Proprietary audits
  • Standards Development and Benchmarking
    • Manufacturing SOP and Records Development
  • Regulatory Status Assessment (GRAS, NDI, ODI, IND)
  • Regulatory Responses (FDA, FTC, TTB)
  • Adverse Event Reporting (AER/SAER)
  • Product and Ingredient Risk Assessment
  • Independent Product Quality Investigations and Corrective Actions/Preventive Actions
  • Quality Assurance Toolbox  for Startups (SOP, Forms)

 

Dietary Supplement Regulatory and Compliance Consultants

Spec Verified™

Ever wonder how your ingredient specifications measure up to regulatory and industry standards?

Spec Verified™  Supplement Ingredient Verification is one of the first independent verification services focusing on evaluating and developing specifications for dietary supplement ingredients.


Dietary Supplement GMP Good Manufacturing Practices

NaturPro Offers Audits of Dietary Supplement GMP Good Manufacturing Practices (21 CFR 111)

The UnLab

NaturPro Scientific is a lab testing advocate for our clients as one of the few “UnLabs” not limited to a particular set of instruments or limitations of a single lab. Working with multiple labs allows us to advocate and work on behalf of our clients, to ensure that correct methods and results are obtained.



Supplement GMP and Quality Assuranc
e

GMP’s now apply equally to supplement manufacturers, ingredient manufacturers, and non-manufacturers who only hold or distribute supplements.  Getting compliant requires a minimum investment and commitment, but we can make it relatively painless.


 

Ethical Sourcing Review™

In collaboration with  standards development firm IDDI and ethnobotanist Trish Flaster from Botanical Liaisons LLC, NaturPro Scientific recently developed the Ethical Sourcing Review™, one of the most comprehensive and stringent standards developed to improve sustainability and traceability of botanical and natural dietary ingredients from the earth.

Spec Verified – Supplement Specification Verification

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Ever wonder how your ingredient specifications measure up to regulatory and industry standards?

Supplement and Ingredient Sustainability and Traceability

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The Ethical Sourcing Review™ is one of the most comprehensive and stringent standards developed to improve sustainability of dietary ingredients from natural sources.

Supplement and Ingredient Sustainability and Traceability

The following outline covers subject matter covered in the 100-part ESR™ Sustainability Questionnaire. ESR™ standards are derived from the International Labour Organization Labour Principles of the United Nations Global Compact, the UN Forum on Sustainability Standards, WHO GAP, NOP Organic, USP <561> and US FDA 21 CFR 111.

Product:

  1. Contact information
  2. Product name
  3. Specifications, nomenclature
  4. Sourcing origin
  5. Land use and inputs
  6. Harvest practices
  7. Plant population care
  8. Raw material processing and labeling

Relationships

  1. Type and controls
  2. Prices and wages
  3. Non-discrimination
  4. Reciprocity
  5. Communications

Employment

  1. Labor practices
  2. Fair wages and prices
  3. Child labor
  4. Harrassment
  5. Working conditions
  6. Worker safety

Environment

  1. Legal requirements
  2. Policies and communications
  3. Management responsibilities
  4. Waste management
  5. Emissions
  6. Energy usage

Management and Supply Chain

  1. Written policies
  2. Training
  3. Supplier management
  4. Dealing with non-compliances
  5. Audit program
  6. Geographic risk
  7. Community improvements

 

Contact us for more information on NaturPro Scientific’s ingredient traceability and ethical sourcing programs. 

 

 

Dietary Supplement Supplier Verification

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Suppliers, manufacturers, marketers and distributors of supplements are better able to manage risk and ensure compliance of supply chain with regulations.

Dietary Supplement Supplier Verification

Our Supplier Verification Process: NaturPro offers flexible plans for supply verification according to GMP. The approach depends on our clients’ individual regulatory requirements, findings from an initial gap analysis included with every audit, and current level of documentation.

NaturPro offers a range of GMP supplier audit services, to comply with FDA requirements for ingredient suppliers, manufacturers, packagers and distributors of dietary supplements. The process of audits for a GAP assessment, vendor qualification, consultation or due diligence is as simple as submitting the appropriate paperwork and scheduling the audit.

  1. Expertise: Experienced auditors with 10+ years experience in international supply chain
  2. Type: Flexible options customized to your needs, including gap analysis, training, self-evaluations, internal audits, multiple standards audits, and mock audits
  3. Format: Desk (documentation) audit, video audits, in-person audits, and combination audits
  4. Project or Subscription Basis: On as-needed contract basis, or ongoing basis to maintain certification.
  5. Facility: Distributor, Manufacturer, Marketer for a range of product types and dosage forms
  6. Reporting: Included are A) GMP Certification or Letter of Opinion benchmarked to a particular approved standard and B) Comprehensive audit and corrective actions reports.

Complying with GMP’s  involves more than keeping your facility in compliance. It’s also essential to verify your supply chain is compliant with the regulation. We can perform supply chain GMP audits as needed at your request or on an ongoing basis to maintain certification.

Supplement and Ingredient Quality Assurance

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Providing Quality Assurance for Natural Products

A number of recent FDA guidances and regulatory actions have clarified requirements to operate a business in dietary supplements, healthy foods and ingredients.

Meanwhile, we find ourselves in an unprecedented climate of consumers demanding quality, purity and transparency, while regulators, class action attorneys and advocacy groups are testing food and supplement products they buy off the shelves with intent.


It has never been more clear that well documented, scientific evidence verifying the quality and safety of ingredients used for dietary supplements and foods is the top priority for any consumer products business.


Identifying your gaps and knowing how to fix them is an investment with high returns on investment. Contact us today for a free pre-assessment.

Services for Supplement and Ingredient Quality Assurance:

 

  • Regulatory Management Support
  • Regulatory Status Assessment
  • Regulatory Support for Dietary Supplements and Foods
  • Regulatory Audits and Compliance Assessments:
    • Regulatory Status Assessments
      • ODI (Old Dietary Ingredients)
      • NDI (New Dietary Ingredients)
      • GRAS (Generally Recognized as Safe)
    • Food Safety and Good Manufacturing Practices (GMP)
      • FSMA (Food Safety Modernization Act)
        • GMP (Good Manufacturing Practices) for Food, 21 CFR 117
        • FSVP (Foreign Supplier Verification Program)
        • PCQI (Preventive Controls Qualified Individual)
      • GMP (Good Manufacturing Practices) for Dietary Supplements, 21 CFR 111,
      • Laboratory Qualification
    • Supply Chain Verification, Development and Assessment
    • Adulteration and Risk Analysis
    • GACP, GAP (Good Agricultural Practices) and GCP (Good Collection Practices)
    • Certified Organic (NOP), Non-GMO, Sustainable (WHO, Fairtrade, etc)
  • SOP (Standard Operating Procedures)
  • Gap Analysis
  • Quality Audits / Compliance Audits
  • Safety Assessments
    • NDI & GRAS Notifications
  • Claims Support (FDA and FTC Claims Substantiation)
    • Label Reviews/Label Development
    • Health Claims, Content Claims and Marketing Content Review
    • Scientific Research Summaries and Reports
    • Technical and Scientific Reviews
  • Good Manufacturing Practices (GMP) Support
    • QA/QC Gap Analysis
    • Quality By Design (QbD) Processes for Natural Products
    • Quality Management Systems Design and Implementation
    • Manufacturing SOP, Manufacturing Records and Batch Records
    • SIDI, Specifications for Dietary Ingredients and Supplements
    • Technical Document Development
    • Certificate of Analysis Review and Approval
    • Material Review and Approval
    • Audit Inspection Preparation and Support
    • Quality Assurance Support & Staffing
    • Quality Assurance SOP, Records and Documentation
  • Supplier Qualification
    • FSVP Programs
    • FSMA-Compliant Third Party Certification
    • Supplier Assessment Programs
    • Supplier Risk Analysis
    • Supplier Self-Evaluation
    • Supplier GMP Checklists
    • Supplier Audits
    • PCQI (Preventive Controls Qualified Invidual)
  • Quality Control
    • Testing and Analysis
    • Material Specifications
    • SDS (Safety Data Sheets)
    • Shelf Stability Studies
    • Testing Plans
    • Product Approval
    • Records Review
    • Data Sheets
    • Certificates of Analysis
    • Method Development and Validation
    • Material Investigations & Dispute Resolution
    • Material Review, Complaints and CAPA Documentation
  • Regulatory Support (FDA, FTC, USDA, International)
  • Product and Ingredient Risk Assessment
  • Crisis Management Support
    • Recalls and Adverse Event Reporting (AER/SAER)
    • Adulteration and Counterfeiting Investigations
    • Scientific Expert Witness
    • Litigation Consulting
  • Due Diligence
  • Merger and Acquisition (M&A) Support

FDA: Procedures and Specifications are Top Concerns

 

 

  

Supplement Testing and Ingredient Quality

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If all you have is a hammer, every problem looks like a nail. We are your toolshed.