Krishn Patel Email & Phone Number

I am a pharmacy post-graduate with a total of 9 Years of Pharmaceutical Industry experience in Regulatory Affairs• CMC authoring of Module 2 and module 3 section.• Review of CMC documents e.g. DMF, Specification, STP, AMV, BMR, PVP, PVR, COA and Stability.• Involvement in base line submission, renewal and post approval changes.• Review of Product development report.• Periodically update of base line submission, renewal and post approval changes in tracker.• Involvement in change control assessment and execution.• Participate in meetings with global regulatory team on a regular basis to understand the client’s requirement for a particular project and proactively support the team in meeting or exceeding the targets in terms of quality and quantity.• Involvement to provide legal documents e.g CoPP, FSC, WHO-GMP Certificates etc.• Timely attend meeting and provide training on CMC guideline.• Maintain different types of tracker e.g assignment tracker, change control tracker, lifecycle update task tracker and learning log.• Involvement in review of artworks.• Arrangement of registration samples and there working standard & impurities for base line submission, renewal and post approval changes.KYE SKILL SETS: • Regulatory/ CMC Strategy and planning.• CMC authoring.• Life Cycle management. • ICH guidelines.• CTD, ACTD.• Change control and Regulatory impact assessment.

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  Senior Consultant, Regulatory Affairs At Continuum India Llp

  Continuum India Llp

  New Delhi, Dl, In