Quality and Regulatory Support

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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)