Guidance For Industry

FDA Research

We find the correct regulatory pathway for your product

FDA Strategy

We help you design your Research and Development Programs to meet FDA Requirements for Approval.

Project Management

We show you how the pieces of the FDA puzzle fit together, and how to save time without sacrificing quality.

FDA Submissions

We prepare regulatory submissions and related files, including:

• New Drug Applications (NDA)
• Abbreviated New Drug Applications (ANDA)
• Common Technical Documents (CTD)
• 510(k) Submissions
• Pre-Market Approval Applications (PMA)
• Drug Master Files (DMF)
• Investigational New Drug Applications (IND)
• Investigational Device Applications (IDE)
• Registrations, Drug and Device Listings
• Comparable Canadian Submissions

FDA Compliance

• We help you Build, Maintain and Audit your Compliance Systems:GMP, GLP, GCP, PDMA , Promotion and Advertising
• Emergency Assistance with FDA GMP Warning Letters and FD 483 Responses

FDA Liason

We provide US Agency Services for Foreign Clients