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Supplement and Ingredient Quality Assurance

Supplement and Ingredient Quality Assurance

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

 

 

  

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