Ravindra M Email & Phone Number

Roles and Responsibilities:Responsible for preparation and submission of the Marketing authorization application to DCG (I) for pharmaceutical and biological products to market in India.Authoring the high quality CMC dossier sections Mobule 2 and Module 3 as per the CTD.Responsible for preparation and submission of application NOC for Form 29, Test Licenses applications, NOC for BA/BE Studies applications, Import license application of Drugs for BA/BE studies, Import Registration Certificate application, Manufacturing license application to DCG (I), CDSCO and State Licensing authority to get the approvals.Evaluation of changes during the post submission period, Submission of Notifications, post approval changes to the approved applications of biological products (Insulin and Its analogues) and pharmaceutical dosage forms. Review of documents such as BMR, Analytical reports (CoAs), Process validation Protocol and reports, Method Validation protocol and reports, Pharmaceutical development reports & Stability data required for regulatory submissions.Review of the quality and analytical data as per the pharmacopoeia specification, Method of analysis, batch records, stability, and finished product/Packaging material data for the purpose of compilation of the dossier.Global clinical trial protocol review and submission to the regulatory authority for Biosimilars/Biologics.Applying the Free sale certificate, Export NOC and COPP certificates.Co-ordination with various cross functional departments like R & D, Analytical development services, QC/QA, Stability department and corporate affairs for the procurement of technical documents required for submissions. Review of change control documents, providing appropriate comments of change controls and summarizing the impact of change on regulatory submission.

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  Drug Regulatory Associate

  Kinapse India Pvt Ltd

  Sep 2014 - Present - Bangalore

  Professional work summary:• Roles and Responsibilities:Responsible for preparation and submission of the Marketing authorization application to DCG (I) for pharmaceutical and biological products to market in India.Authoring the high quality CMC dossier sections Mobule 2 and Module 3 as per the CTD.Responsible for preparation and submission of application NOC for Form 29, Test Licenses applications, NOC for BA/BE Studies applications, Import license application of Drugs for BA/BE studies, Import Registration Certificate application, Manufacturing license application to DCG (I), CDSCO and State Licensing authority to get the approvals.Evaluation of changes during the post submission period, Submission of Notifications, post approval changes to the approved applications of biological products (Insulin and Its analogues) and pharmaceutical dosage forms. Review of documents such as BMR, Analytical reports (CoAs), Process validation Protocol and reports, Method Validation protocol and reports, Pharmaceutical development reports & Stability data required for regulatory submissions.Review of the quality and analytical data as per the pharmacopoeia specification, Method of analysis, batch records, stability, and finished product/Packaging material data for the purpose of compilation of the dossier.Global clinical trial protocol review and submission to the regulatory authority for Biosimilars/Biologics.Applying the Free sale certificate, Export NOC and COPP certificates.Co-ordination with various cross functional departments like R & D, Analytical development services, QC/QA, Stability department and corporate affairs for the procurement of technical documents required for submissions. Review of change control documents, providing appropriate comments of change controls and summarizing the impact of change on regulatory submission.Submission of response to the queries raised by regulatory authorities