Plan, design and implement DoE for robust product/process development in compliance with regulatory agencies, for US, Europe and Japan markets.
Literature and patent search, analytics, review, scientific discussion and documentation.
Application for Test License, Import License and activities to obtain Product Clearance.
Execution of pre-formulation and trial batches for formulation development.
Preparation and management of stability batches, stability data collection and compilation.
Execution of Demo batches for technology transfer to Location.
Preparation of Master Manufacturing Document (MMD), Bill of Materials (BOM) and Export Purchase Order (EPO)
Product Development Report (PDR) a...