Pratikkumar Patel

Sr Research Scientist and Aqpic @SteriMax Inc.

Oakville, ON, CA

Conduct a comprehensive review of the CMC (Chemistry, Manufacturing, and Controls) sections in the dossiers and propose strategies to address any identified review gaps to minimize risks.• To support in coordinating responses to feedback from Health Canada and business partners, providing timely and scientifically sound explanations and solutions.• To oversee laboratory activities in the absence of the Manager, ensuring continued operations and the seamless progression of tasks. • Have been involved in responding to external lab feedback and inquiries independently, ensuring that all concerns are addressed promptly and effectively.• I am serving as the AQPIC to facilitate the issuance of Standards and Samples, as well as the reconciliation of sample inventory in compliance with Health Canada guidelines.• Perform analytical method development, method validation, forced degradation studies and method transfers.• Prepare analytical methods, protocols, reports and other documents related to analytical development and validation activities.• Development and qualification of methods required for functional characterization of biopharmaceutical products including planning, execution, and documentation• Execution of various studies involved in biological characterization of molecules like stability studies, functional similarity studies, structure function relationship studies etc.• Support formulation development for analytical testing related to stability, compatibility and pre-validation studies.• Perform root cause analysis including OOS and OOT and independently troubleshoot method related problems.

APMC College of Pharmaceutical Education & Research

Master of Pharmacy (M.Pharm)

Shree swaminarayan sanskar pharmacy college

Bachelor of Pharmacy (B.Pharm.)