Regulatory experts
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Regulatory Specialist with 7+ years of experience in the pharmaceutical pre- and post- approval regulatory Submissions to MHRA & EMA and USFDA . It includes Regulatory Strategy Planning Submission of ANDAs IND and NDA and post-approval, CMC changes for variations filing to Regulatory agency. Preparing the Product annual reports and Regulatory responses letter.
Reviewing the regulatory compliance and compiling the dossier for submission, Expertise in evaluating quality documents in liaison with SOPs and regulatory guidelines.
Regulatory Specialist with 7+ years of experience in the pharmaceutical pre- and post- approval regulatory Submissions to MHRA & EMA and USFDA . It includes Regulatory Strategy Planning Submission of ANDAs IND and NDA and post-approval, CMC changes for variations filing to Regulatory agency. Preparing the Product annual reports and Regulatory responses letter.
Reviewing the regulatory compliance and compiling the dossier for submission, Expertise in evaluating quality documents in liaison with SOPs and regulatory guidelines.
