Quality and Regulatory Support

Ensuring Comprehensive Regulatory Compliance for Clinical Success

Suppliers must maintain outstanding Regulatory Compliance in order to ensure your development program will be achieve an FDA approvable status for both NDA and ANDA programs. DDA has partnered with a regulatory firm that will ensure your suppliers have the regulatory requirements in place to ensure a FDA approvable status supporting your clinical candidates. Compliance and training are available in the following areas:

Clinical Supplies Project Management
Quality Assurance and Quality Compliance
Auditing
Training
Controlled Drug Substances (DEA) Consulting and Training
Medical Devices, In-vitro Diagnostics (IVDs), and Combination Drug/Device Products
Regulatory Compliance and Submissions
Staffing
SOPs
Due Diligence Services for Venture Capital Firms
Dietary Supplements (21 CFR Part 111)
Comparator Drug Sourcing
Clinical Supplies Support Group (CSSG)

Author
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Deborah Minor

CEO at Drug Discovery Alliances

Deborah has decades of business development experience marketing contract services, drug licensing and new technologies to the pharmaceutical industry. She founded Drug Discovery Alliances, Inc. in 2001 to connect pharmaceutical and biotech companies with top industry contractors who facilitate and speed projects. Deborah earned a Ph.D. in Medicinal Chemistry from University of North Carolina, Chapel Hill and has worked as an organic chemist for Rhone Poulenc. She subsequently worked for Accelyrs and MDL, marketing molecular modeling technologies and databases including Beilstein and Crossfire to the pharmaceutical industry.