NaturPro Services

360º Product Development

1. Innovation Strategy
2. Intellectual Property Development;
3. Patent/trademark development and licensing
4. Product Costing and Financials
5. Product Prototyping and Piloting
6. Regulatory Status / Safety Assessment
7. Market Analysis, Positioning & Competitive Analysis
8. Ingredient Readiness
9. Supplier Qualification
10. Formulation Strategy
    • Safety
    • Ingredient Type
    • Dosages
    • Costing
    • Benefits & Claims
    • Flavoring
    • Shelf Stability
    • Supplier Identification
    • Labeling
11. Prototypes and Samples
12. Manufacturer Qualification & Negotiation
13. Pilot Manufacturing
14. Commercial-scale Manufacturing & Operations

Regulatory Support for Brand Owners

1. Regulatory Strategy
2. Standard Operating Procedures (SOP’s)
3. Gap Analysis & Risk Assessment
4. Food Safety Plan, HACCP Plan
5. FSVP (Foreign Supplier Verification Program)
6. GMP’s, Specifications, and Analytical Testing
7. SOP (Standard Operating Procedures)    
8. Product Formulation & Recipes
9. Manufacturing Records & Batch Records
10. Quality Control & Measurement – Lab Testing
11. Specification Development
12. Spec Verified — Specification Review
13. Supplier Verification & Traceability     
14. Supplier Qualification
15. Commercialization and Scale-Up
16. Claims Development and Substantiation
17. Manufacturing Feasibility
18. Contract Manufacturer Qualification and Negotiation 
19. Sourcing & Supply Chain
20. Source and qualify bulk raw materials and ingredients
21. Packaging & Label Development
22. Process Development
    
    

 

Expert Assessments

1. Technical Evaluation & Testing
2. Claims Development & Substantiation
3. Technology Valuation & Improvement
4. Safety & Regulatory Assessments
5. Research, Surveys & Clinical Studies
6. Market & Competitive Analysis
   
   

Quality Control & Product Testing

1. The UnLab for Independent, Scientifically Valid Results
2. Laboratory Qualification
3. Method development, optimization and validation
4. Material Sampling & Testing
   1. ID Verified– Ingredient Identity Verification
   2. Potency
   3. Bioactivity
   4. Purity & Contaminants
   5. Consumer Preference

Research & Development

1. Formulation R&D (e.g. flavoring, solubility, processing)
2. Prototypes and Samples
3. Shelf Stability Plan
4. Consumer Preference Studies
5. Health Surveys (e.g. Fatigue, Pain, Digestive Discomfort)
6. Side Effects Evaluation
7. Product Trial Surveys
8. Virtual Clinical Trials
9. Human Efficacy Trials
10. Bioactivity & Mechanism of Action
11. Safety & Allergenicity
12. Microbiology
13. Nutritional Analysis
14. Testing to Label Claims
15. Testing to Regulatory Limits

     

Technical Support

1. White Papers
2. Technical Reports
3. Executive Summaries
4. Market Research
5. Technical Marketing Materials 
6. Product Presentations
7. Claims Development & Substantiation
8. Master Product Files
9. Product Monographs
10. Fact Checking
11. Competitor Surveillance
12. Social Media Monitoring
13. Standards Development
14. Standards Marketing
15. Truth-in-labeling Programs

Sustainability

1. Ethical Sourcing Programs –Based on global standards incl. WHO, FairTrade
2. Ethical Sourcing Self-assessment 
3. Desk and In-person Audits

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Regulatory Compliance Services

1. Regulatory Support
2. Regulatory Status Assessment
3. Regulatory Support for Dietary Supplements and Foods
4. 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) –
       • Supplier Verification (FSMA/21 CFR 117)
     • PCQI (Preventive Controls Qualified Individual)
     • GMP (Good Manufacturing Practices) for Dietary Supplements, 21 CFR 111,
       • ID Verified™ for identity (21 CFR 111)
       • Spec Verified™ for product specifications (21 CFR 111)
     • Laboratory Qualification
   • Supply Chain Development and Assessment
   • GAP (Good Agricultural Practices) and GCP (Good Collection Practices)
   • Certified Organic (NOP), Non-GMO
   • Sustainable (WHO, Fairtrade, etc)
5. SOP (Standard Operating Procedures)
6. Quality System Gap Analysis
7. Quality Audits / Compliance Audits
8. Safety Assessments
   • NDI & GRAS Notifications
9. 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
10. 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
11. Supplier Qualification
    • FSVP Certification
    • FSMA-Compliant Third Party Certification
    • Supplier Assessment Programs
    • Supplier Risk Analysis
    • Supplier Self-Evaluation
    • Supplier GMP Checklists
    • Supplier Audits
    • PCQI (Preventive Controls Qualified Invidual)
12. 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
13. Regulatory Support (FDA, FTC, USDA, International)
14. Product and Ingredient Risk Assessment
15. Crisis Management Support
    • Recalls and Adverse Event Reporting (AER/SAER) 
    • Adulteration and Counterfeiting Investigations
    • Scientific Expert Witness
    • Litigation Consulting
16. Due Diligence
17. Merger and Acquisition (M&A) Support

Coaching & Training

1. GMP & Regulatory Training
2. FSMA Training
3. QA/QC Training
4. FDA Inspection Training
5. Training Materials
6. Training SOP and Records
   
   

Product Types

1. Agricultural Products
2. Animal Feed
3. Animal Products
4. Botanical Drugs
5. Botanicals
6. Cannabis, Hemp & Medical Marijuana
7. Capsules & Tablets
8. Carbohydrates
9. Conventional Foods
10. Cosmetics & Skin Care
11. Dietary Ingredients
12. Dietary Supplements
13. Dispersions
14. Essential Oils
15. Extracts
16. Food Ingredients
17. Food Ingredients & Additives
18. Food Supplements
19. Functional Foods
20. Lipids
21. Liquids
22. Medical Foods
23. Minerals
24. Natural Health Products
25. Natural Product OTC & API
26. Natural Products
27. Natural Product Drug Discovery
28. Packaging
29. Pet Supplements
30. Phytochemicals
31. Powders
32. Probiotics, Yeast and Microorganisms
33. Protein
34. Range of Product Formats
35. Raw Materials
36. Reference Materials
37. Specialty Products
38. Transdermal Products
39. Vitamins
40. Whole and Tea Cut Herbs
41. Wildcrafted Herbs
    
    

Contact Us

1. Email: [email protected]
2. Call/Text: (317) 727-9173
3. Website: www.npscientific.com
4. Twitter: @NaturalBlake
5. Instagram: @NaturPro