Ms. Gowri Sukumar

Area Of Expertise : Pharma
20 Years Of Experience
Training Industry : Life Sciences

Gowri Sukumar is the Director, CMC and Regulatory Affairs for Iterion Therapeutics, Houston, TX. Unique to her experience is leading all the technical disciplines of CMC development as well as regulatory Affairs. She has broad responsibilities that include process development, Drug Substance and Drug Product manufacturing from the CMC side. From the Regulatory affairs perspective, she provides regulatory leadership and expertise for regulatory strategy, liaises with the regulatory agencies including FDA, Health Canada and other Health authorities. For her leadership approach, she brings a strong focus beyond the necessary technical disciplines and regulations, looking at the interplay of culture and teamwork for successfully advancing programs in an effective and efficient manner.  Gowri holds a master’s Degree in Biosciences as well as the prestigious Regulatory Affairs Certification (RAC) awarded by the Regulatory Affairs Professional Society.  She is the author or co-author of several peer-reviewed research publications as well as book chapters. Gowri has breath of experience spanning R&D, CMC and Regulatory affairs. She also serves as a reviewer for several international Bioscience Journals for providing Scientific and technical expertise.

4 results Found
Live Webinar

Vendor Qualification in Pharma Industry

This webinar will provide insights on building sustainable vendor qualification program specific to the FDA regulated industries. Will shed light on the importance of Vendor qualification and on each and every step involved in the process a ...

  • Basic & Intermediate & Advanced
  • 60 Mins
  • Apr 07, 2020
Recorded Webinar

Sponsor's responsibilities for an Active Investigational New Drug (IND)

This webinar will shed light on all the sponsor’s responsibilities for an Active Investigational New Drug application (IND). Alongside this presentation would detail each of the sponsor’s activity in greater detail including timelines to im ...

  • Basic & Intermediate
  • 60 Mins
Recorded Webinar

Understanding Initial IND Submission- The first 30 days

This webinar will shed light on the entire process that takes place from the time the sponsor submits the initial IND to the FDA for initial 30-days. Alongside this presentation would detail the various grounds on which the FDA may consider ...

  • Basic & Intermediate
  • 60 Mins
Recorded Webinar

Review of Chemistry, Manufacturing and Controls (CMC) of an Investigational New Drug Application (IND)

Outline of the relevance of information from the CMC perspective Understanding differences between small molecules and Biologics Glimpse of CFR 312.22 with the highlight on the FDA’s primary objectives in reviewing an IND Overview of P ...

  • Basic & Intermediate
  • 60 Mins