16 Aug
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DISHMAN CARBOGEN AMCIS
|
Ahmedabad
16 Aug
DISHMAN CARBOGEN AMCIS
Ahmedabad
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.
- Reviewing analytical method validation reports, stability protocols, concerned standard operating procedures and adding regulatory input to make it in line with regulatory authorities
📌 Senior Executive (Ahmedabad)
🏢 DISHMAN CARBOGEN AMCIS
📍 Ahmedabad