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)