Pharmaceutical
Development






We offer you support in the following areas of pharmaceutical product development.






Ingredients



  • Definition of "starting material under consideration of GMP requirements and ICH Q11


  • Preparation of an Active Substance Master File (ASMF) for drug approval application


  • Compiling the ASMF into the electronic Common Technical Document [eCTD] format for electronic submission


  • What are the minimum requirements for data in terms of development, manufacturing, specification, analysis and stability







Graphic to ingredients






Pharmaceuticals



  • Which documents are required for the preparation of the quality part (CMC/module 3) for a drug approval application


  • What are the minimum requirements for data in terms of development, manufacturing, specification, analysis, packaging and stability


Graphic to drug development






Generally



  • Interaction with regulatory agencies during pharmaceutical development to discuss critical issues (Scientific Advice Meetings)


  • Noncommittal preliminary discussions to assess the feasibility of a planned ingredient or drug development and which timing or financial requirements have to be met


Graphic to Scientific Advice Meetings