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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.

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 DMF's to the U.S. FDA, and we have a broad range of experience in submitting DMF's 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)

For more information on our Drug Master Files (DMFs), please fill out the form below.