Preparation of DMF / ASMF / CEP dossiers as per the ICH M4 CTD/eCTD guidelines.
Preparation of response to queries raised by various regulatory agencies customer.
Preparation of Applicant s Part of ASMF as per customer requirement and restricted part of ASMF as per regulatory requirement.
Initiation of activity for timely notification / prior approval from regulatory agencies in case of any changes required to the existing DMF / ASMF / CEP on ongoing basis
Initiation preparation of renewals or revisions for CEPs / annual reports for USDMFs / ASMF variations.
Keeping update about the current global regulatory requirement
Evaluation of change control applications for regulatory implications.
1. Reviewing analytical method validation reports, stability protocols, concerned standard operating procedures and adding regulatory input to make it in line with regulatory authorities