Pratikkumar Patel Email & Phone Number

Oakville, Ontario, Canada

 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. 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 Plan 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 prevalidation studies. Perform root cause analysis including OOS and OOT and independently troubleshoot method related problems. To support regulatory team in responding to queries received from regulatory authorities.

Montreal, Quebec, Canada

✓ Conducted Analytical Method Development, Validation (AMV) and Transfer (AMT) for Veterinary formulations such as Sterile Injections, Soft Chews, Soft Gelatin Capsules, and Tablets.✓ Performed Analytical Method Development for Related Substance, Assay, Cleaning Method with its documentation.✓ Prepared Method Development and Validation Report for Analytical Methods of different tests.✓ Reviewed VMF and COAs of Drug Substance and excipients from different vendors and make the compilation to select best suitable vendor for API Sourcing. ✓ Carried out routine analytical activities, compiling all data and support to formulation development department to optimize the formulations.

Ahmadabad, Gujarat, India

✓ Performed Analytical Method Development and Pre-Validation (AMV) for formulations such as Peptide, Injectable Emulsion, Lyophilize Injection and Premix Injection.✓ Performed Analytical Method Development for tests such as RS, Assay, Cleaning Method, Excipient Content such as Antioxidants, Preservatives, Lipids and Impurities of Excipients (Lipid, Egg Lecithin) such as LysoPhosphatidylcholine, Free Fatty Acid etc. with its documentation.✓ Coordinated cross-functional team to facilitate progress in various ANDA projects.✓ Carried Out Calibration of Analytical Instruments as per calibration schedule.✓ Reviewed DMF and COAs of Drug Substance and excipients from different vendors and make the compilation to select best suitable vendor for API Sourcing. ✓ Implemented ALCOA principles, GLP practice, LIR Investigation as applied to analytical development.

Ahmedabad Area, India

✓ Performed Analytical Method Development, Analytical Method Validation (AMV) and Analytical Method Transfer for Liposomal, Peptide, Nanoparticles, Lyophilize Injection and its documentation.✓ Planned and Performed accurate routine analyses on finished products and stability sample of different dosage forms as per schedule.✓ Prepared Method Development and Validation Reports, STPs, OOT and OOS within stipulated time line to meet regulatory submission.✓ Handled individual projects from inception to filing.✓ Imparted appropriate training on analytical instruments and SOPs to new joiners.

Ahmedabad Area, India

✓ Performed analytical method development and validation of Assay, Related substances, cleaning method of various pharmaceutical dosage form. ✓ Performed stability study, forced degradation study, and excipient compatibility study of products.✓ Actively Identified and resolved problems in routine analysis of new formulation.

Vadodara, Gujarat, India

✓ Performed routine analysis of finished product and stability Samples at a predefined schedule of various pharmaceutical dosage forms, such as Liposomes, Microspheres, Tablets, Capsules, Injectable, Suspension and Cream.✓ Worked on product-related FDA or Plant queries, Admixture studies, Photostability studies, Compatibility studies, forced degradation, and Reverse Engineering.

Ahmedabad

✓ Performed Analytical Method Transfer and Stability Study for Injectable Product and its Documentation.✓ Carried out calibration of HPLC and its documentation.✓ Involved in developing and validating analytical methods for drug substances and drug products as per ICH or USP guidelines.✓ Got effectively trained in newer analytical techniques and instrumental methods of analysis

Master Of Pharmacy (M.Pharm), Quality Assurance, Distinction

Dissertation titled “Analytical Method development and Validation for Simultaneous estimation of Aspirin and Dipyridamole in Marketed.

Bachelor Of Pharmacy (B.Pharm.), Pharmacy, First