Regulatory & CMC Support

At Goodwin Biotechnology, we provide you with expert Regulatory Support Services to assist in quickly and effectively moving your drug candidates through the regulatory application and review process. Goodwin Biotechnology provides full Regulatory Support Services for projects beginning with process development initiatives in support of toxicology study materials through the preparation of Chemistry, Manufacturing & Controls (CMC) information for IND filings and amendments. Our staff provides regulatory CMC assistance in all aspects of client projects including meeting with regulatory agencies to discuss CMC development, as well as CMC manufacturing and testing issues. Our staff is knowledgeable in US, Canadian, and European requirements, as well as guidelines for products produced using novel platforms.

Drug Master Files (DMFs)

Goodwin Biotechnology has established a Drug Master File (DMF) with the FDA.

Goodwin Biotechnology also has substantial experience in submitting type II DMFs to the U.S. FDA, and we have a broad range of experience in submitting DMFs for active pharmaceutical ingredients, Drug Products and IND’s for biologic products. Goodwin Biotechnology strictly adheres to the regulations associated with the development of every new pharmaceutical ingredient, biologic product.

Goodwin Biotechnology offers:

  • Manufacturing that is fully committed to ensuring that our manufacturing process comply with international regulations for current Good Manufacturing Practice (cGMP).
  • Custom Manufacturing operates process oriented quality management systems based upon international quality standards. Our site has been inspected by the FDA and other national health agencies to enable our products to be used by our customers in the United States, Europe, Asia, and many other regulated markets.
  • Decades of experience in the analysis of biological materials.
  • Experience of performing testing on over 150 recombinant proteins and monoclonal antibodies per FDA and EU requirements.
  • Experienced in handling FDA and EU regulatory agency inspections.
  • Preparation or review of IND submission documentation (CMC sections).

We Welcome Audits

Over the years, we have had more than 85 audits from:

  • FDA, as well as Health Canada, the EMEA and other regulators.
  • Customers
  • Auditors

We welcome the opportunity to host an audit from your company or representative.

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Drug Master Files

Contact Us to learn how we can support your regulatory and CMC efforts or to learn more about our Drug Master files.