Ketan Agravat

Founder, Chief Consultant

https://www.linkedin.com/in/ketanagravat/

Regulatory & Quality are the backbone of the industry and should help the company provide safe & effective medicines to patients ensuring compliance with company policy, federal regulations & Laws with faster approvals.

Firm Believer in practical regulatory submissions helps a company achieve Business Goals, initiate Cost Reductions, and comply with Regulatory Affairs.

  • 25 plus years of experience in the pharmaceutical industry as an organic chemist

  • Last 15 years in the field of Regulatory Intelligence and Compliance for Active Pharmaceutical Ingredients (API) & FDF

  • Managed Teams of Regulatory & Quality professionals across functions of SCM, RA & QA

  • Experience in dealing with regulatory agencies like USFDA, EDQM, ANSM-France, ANVISABrazil, TGA-AU and many more

  • Engaged with Industry associations on OOS, QbD, Risk Management Plan, Change Management, Technology Transfer and many more subjects

  • Instrumental in setting up regulatory affairs and initiate regulatory filings (Paper as well as Electronic versions) in many companies during the career span

  • Was actively engaged with NIPER (National Institute of Pharmaceutical Education and Research) Chandigarh as Guest faculty for the courses on regulatory affairs (API) and other universities/colleges for various educational activities

The Team

Our Regulatory Team collectively having more than 60 years of experience. We collaborate with consultants based on need on projects. Our Regulatory Team has exposure to Global Regulatory Submissions, its Life Cycle Management, Change Management, Gap Analysis, Pre-Submission Audit, Regulatory Intelligence, Regulatory Compliance.

Our Quality Team collectively has more than 60 years of experience in Establishing Quality System, Quality System Gap Analysis & its Compliance, Audit Management, Regulatory Authority Inspection Preparation, third party audit, etc.

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