1. Handling filing of ANDA(its for us ,eu market) for USFDA.
2. Review of formulation related documents like PDR (as per QBD concept), BMR, BPR, stability protocols & Stability Data.
3. Handling post approval changes, PAS and supplement filing.
4. Handling query responses submission
5. Review of Specification, CQA of API, raw material, Packaging material and finished Products.
6. Compilation of Documents as per eCTD requirement for CMC section for module 1 to Module 3 and annual updates.
7. Co-ordination with documentation department, formulation development, manufacturing location for revision of Specification and standards test procedure.
We are an Executive Search & HR Consultancy is a young emerging organization... established by HR professionals with the objective of providing comprehensive staffing & Manpower solutions to the organizations.
We believe in understanding the clients business, so as to proactively align the HR process with the business needs of our clients. We believe in providing a solution for all the HR related activities. Read full description