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:
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Development activities for generic Drug Substance and Drug Product
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All dosage forms
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Exploratory development / pre-formulation study design
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Formulation optimization
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Manufacturing process development and optimization
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Process validation
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Scale up
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Clinical trial supply
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Review of scientific and technical development reports