Services Offered
Executive Regulatory & Quality Assurance Advisor
Consultations for Start-ups and Established Businesses
Regulatory and Quality Compliance Advisor
Fractional VP of QA and Regulatory Affairs
Formula Development and Compliance Assessment
Marketing Claims Development and Product Description Page Reviews (eg. Amazon Listings)
Full Label Compliance Review
Regulatory/Quality Assurance Training
Custom SOPs For Brand-Owner Operations
Acting Compliance Officer or “Quality Assurance Person” For Your Company
Contract Manufacturer Vetting and Audits
Test Parameters & Product Specifications Development
Product Recall Execution
Supplier Compliance Audit and Gap Assessments
Regulatory & Quality Contractor
Supplement Startup Launch Activities
1:1 Consultations and Mentoring For Entrepreneurs New To Supplement Requirements
Supplement Startup Essential Training For Entrepreneurs and Influencers
Product Formulating, Claims Development, Product Testing
Label, Website and Amazon Product Page Compliance
Vetting Contract Manufacturers and More
Regulatory Compliance Activities
Regulatory Label Review & Training
Product Claims Review & Substantiation
Product Development & Regulatory Strategy
Website Compliance Assessment
Product Registrations
Structure/Function claims Notifications To FDA
Marketing and Collateral Review
California’s Prop 65 Mitigation
Quality Assurance Activities
Suite of Standard Operating Procedures (SOPs) Templates
Customized Suite of SOPs Tailored To Your Business
Contract Manufacturing Audits and Assessment
Label Development
Creation of Finished Product Specifications
Shelf-Life Protocol Design
GMP Manufacturing Contracts (“GMP Agreements”)
Business Contract Review
Adverse Events Reporting and Complaints Handling
Crisis Management
Crisis Management Plan and Simulation Training
Recall Plan and Simulation Training