Email: enquiries@bioventurescl.com

Regulatory Affairs & Product Development Services

The Application of Strong Scientific Understanding

Quality Overviews and CMC dossiers (3.2S, 3.2P, DMF)

BioVentures Consulting Limited will emphasise the key parameters and identify where guidelines have not been followed

BioVentures Consulting Limited can compile the Quality Overall Summary (Module 2.3) working with relevant members of its client’s CMC team directly, or else, in cases where manufacture is contracted out, with its 3rd party providers. BioVentures Consulting Limited will emphasise the key parameters and identify where guidelines have not been followed. Importantly, we will discuss key issues including those that integrate with other modules.

BioVentures Consulting Limited also has expertise from working in a number of biological manufacturing facilities, and in compiling both the drug substance and drug product bricks. As such BioVentures Consulting Limited can work with clients to compile:

  • the manufacture, characterisation, control of drug substance
  • reference standards
  • container closure systems
  • stability sections of the Drug Substance Module 3.2 components.

Further BioVentures Consulting Limited is also able to offer services in the compilation of:

  • pharmaceutical development
  • manufacture, control of excipients, control of drug product
  • reference standards
  • container closure system
  • stability sections of the Drug Product Module 3.2 components. 

In cases where companies producing Module 3.2 Drug Substance and 3.2 Drug Product sections are different BioVentures Consulting Limited is able to work with either party on the open and closed sections of the Drug Master File (DMF) as appropriate. In addition, in some situations, BioVentures Consulting Limited may recommend the submission of a Certificate of Suitability, including the submission of the Drug Substance information and the QOS to the European Directorate of Quality of Medicines (EDQM). 

For more information contact us on: This email address is being protected from spambots. You need JavaScript enabled to view it.

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