Dietary Supplements are a significant market in the consumer wellness industry, yet regulations about formulations and labeling can be challenging for manufacturers to navigate.
Our veteran consultants provide services to ensure your products meet federal standards, including ingredient assessment and label wording to ensure categorization as a supplement rather than an FDA unapproved drug.
Experience & Capabilities
FDA Compliance Consulting
Project Management
FDA 483 / Warning Letter
Consent Decrees
Systems Monitoring
GXP Training
Product Submissions
Due Diligence
Product Reviews
Registration & Listing
Audits
Gap Analysis
Regulatory Strategies
Inspection Preparation
GMP Services
GCP Services
FDA Submissions
Clinical Development
Nonclinical Development
Risk Based Assessment
Combination Products
Staff Augmentation
Electronic Publishing
Program Design