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Chemistry transferred to GMP

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Organic, inorganic, polymeric

The transfer of chemical processes to fully cGMP compliant manufacturing is a challenge that requires up-to-date regulatory and technical expertise, a state-of-the-art infrastructure. ChemCon specializes in the seamless transition from synthesis scale up to cGMP production. You can find more information on our commitment to cGMP standards under Quality.

Beyond the course of your project in the lab, we can advise you in any related matter at any time, may it be of regulatory significance or concerning the selection and validation of the correct analytical methods. All steps of method development are documented. 

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Step 2: First cGMP material for clinical trials or registration

  • vendor qualification for cGMP starting material
  • process scale-up to your requirements
  • seamless process transfer from R&D to cGMP
  • production campaigns on a gram to multi-kilogram scale
  • preparation of all necessary cGMP documents
  • validation of analytical methods
  • release packages
  • regulatory support

Step 3: Commercial production ▶

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