Quality, CMC Development

Review of CMC documents (IMPD, IND, CTD) for a Marketing Authorization Application (MAA) or New Drug Application (NDA) and advice during the pharmaceutical development of different kind of dosage forms.

Target clients: pharmaceutical companies, especially small and medium sized ones, and other organisations developing e.g. generic drugs which need support during the development process.

The specifically tailored service include:

  • Development activities for generic Drug Substance and Drug Product

  • All dosage forms

  • Exploratory development / pre-formulation study design

  • Formulation optimization

  • Manufacturing process development and optimization

  • Process validation

  • Scale up

  • Clinical trial supply

  • Review of scientific and technical development reports

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