Aniket Kadam
Regulatory Affairs Executive @Lupin
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WORK HISTORY
Regulatory Affairs Executive @Lupin
Mumbai, IN
Compilation, Publication and Submission of quality dossier (Module 1 to 5 for complex and critical ANDA submissions, like NCE-1, First to File (FTF), FTM, CGT, PFC etc.2. Worked on filed product deficiency received from USFDA and submitted within said time frame.3. Strategise and Submits Post Approval Supplements like CBE-0, CBE-30 and PAS (Prior Approval Supplements).Note- Well versed with end to end Regulatory Activities from original submissions to Life Cycle Management
ABOUT ANIKET KADAM
Hands on review, submission and publication of high-quality dossier for solid oral…
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