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

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

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