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)
Deborah Minor