FDA Regulatory Submissions, Regulatory Compliance Consultants, Quality System, Training, Documentation
The Tamarack Group (Carol DeSain) offers Regulatory, Quality System/GMP Compliance, and Quality Assurance consulting for product and process developers and manufacturers of pharmaceutical, device, diagnostic, biologic and bio-pharmaceutical medical products who distribute their products in markets regulated by the US FDA, the European Commission , and other international regulatory agencies.
The Tamarack Group expertise draws from different disciplines in the life sciences to help minimize risks
and uncertainties inherent in medical product development and manufacturing. Our broad consulting
experience and strategic insights help develop regulatory approval strategies and CMC support for IND, NDA and BLA regulatory filings, and Risk Management Plans.
The Tamarack Group also provides helpful books, articles, and example documents. Books include Documentation Basics, Documentation Practices and Risk Management Basics. Examples include Quality System Process Maps.