Quality and Regulatory Support

Quality and Regulatory Support

You can get quick access to a number of our services by making just one phone call.

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)

20 Years

Of experience serving the drug discovery market.

$100 Million

In transactions between pharmaceutical companies and our global supplier base.

200+

Biotech programs brokered to date.

Ready to see how we can help you hit your R&D goals?

Please don’t hesitate to reach out to us today to discuss how we can help you reach your objectives.

WBENC

Drug Discovery Alliances was recently certified by the Greater Womens Council and received the Women’s Business Enterprise National Council certification.

HUB Zone certification

Drug Discovery Alliances was recently HUB Zone Certified.