+ Drug Product registration/re-registration and import+ Preparation of Schedule-DI, Schedule-DII, Plant Master File in Compliance with applicable regulatory guidance.+ Dossier Submission (NDA, ANDA) in CTD/ eCTD format + Module-2 (CTD summaries) & Module-3 (Quality) preparation+ CMC knowledge support and Preparation of DMF (Type-II)+ Medical device registration/re-registration and import+ 510(K) support+ Wholesale License (Form-20B & Form-21B)+ Product life cycle Maintenance+ Biological/Biotechnology Product Application+ To submit Clinical trial application and also notify and submission of variations/ amendments/annual reports as applicable to regulatory requirements+ Understand and interpret international medical device regulatory requirements; provide guidance on regulatory requirements + Develop strategies for submissions to regulatory agencies. Provide regulatory risk assessments and options + To maintain lists/documents/records+ Actively participate in the development of regulatory skills within the regulatory team by continuous up-dating with new regulation+ Query Response to Regulatory Authorities & Client with respect to the product

RegulatoryBA/BE study Dossier Submission, Notification to DCG (I) before conduct of studies, Acknowledgement to DCG (I),Facility approval dossier submission, Import License (Test & Analysis),Export NOC for Biological (Plasma),Monthly report submission to State DCG (I),Clinical Trial Application, Query response to DCG(I), Regulatory manual prepration and update as per new regulatory changesProject ManagementPreparation and sharing of templates for BA/BE, Clinical Trial submission, review of documents from sponsor and providing inputs, Project activity, timeline preparation and sharing coordinating with departments for timely report submission to sponsor, sharing the project update weekly with sponsor through conference

BA/BE study Dossier Submission, Notification to DCG (I) before conduct of studies, Acknowledgement to DCG (I), , Import License (Test & Analysis),Export NOC for Biological (Plasma),Query response to DCG(I), Internal audits to check compliance with applicable regulations, Literature search (Clinical/Preclinical) to support BA/BE application.

Non Clinical/ Pre- clinical Studies related to CTD Module-4 under GLP conditionsScreening of New Chemical entityIn-vitro Assay (Antibacterial)MIC, MBC PAE.Development and testing In-vitro Pharmacokinetics assayIn-Vivo Efficacy studies (Mice & Rat Models)Pharmacodynamic study Animal Models developmentPharmacokinetic studies with animals