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PHARMACEUTICAL QUALITY AND REGULATORY SUPPORT

All of DDA's partner suppliers must uphold exemplary regulatory compliance certifications to ensure that your development program meets the stringent requirements for FDA approval, whether for NDA (New Drug Application) or ANDA (Abbreviated New Drug Application) submissions.

We help connect developers with quality controlled suppliert, optimizing your drug development process.

Ensuring FDA Approval with Top-Notch Regulatory Compliance

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:

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  • 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)

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