Pharmazeutische Entwicklung
Pharmaceutical
Development
We offer you support in the following areas of pharmaceutical product development.
Ingredients
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Definition of "starting material under consideration of GMP requirements and ICH Q11
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Preparation of an Active Substance Master File (ASMF) for drug approval application
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Compiling the ASMF into the electronic Common Technical Document [eCTD] format for electronic submission
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What are the minimum requirements for data in terms of development, manufacturing, specification, analysis and stability
Pharmaceuticals
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Which documents are required for the preparation of the quality part (CMC/module 3) for a drug approval application
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What are the minimum requirements for data in terms of development, manufacturing, specification, analysis, packaging and stability
Generally
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Interaction with regulatory agencies during pharmaceutical development to discuss critical issues (Scientific Advice Meetings)
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Noncommittal preliminary discussions to assess the feasibility of a planned ingredient or drug development and which timing or financial requirements have to be met
