Lipi Thakkar Email & Phone Number

I have a Master's in Regulatory Affairs in Medical Devices and Drug Biologics. Earlier, I completed my Bachelor's in Pharmacy and worked as a QA intern in the pharmaceutical industry, where I became familiar with auditing, CAPA, and maintaining documentation. I also got a hands-on opportunity working in a laboratory as a formulation co-op in the Research and Development team, focusing primarily on lipid nanoparticle preparation and characterization.During my Master's degree, I learned the following courses:Introduction to FDA Compliance, Medical Device Regulations, Product Development, and Lifecycle Management Safety science in the medical device industry, Human experimentation, legal issues, medical device development, Advanced Regulatory Writing, Strategic planning and project management for Regulatory Affairs, Therapeutic Product Development overview.• I have developed knowledge about pharmaceutical and medical device strategy management, which includes IND, NDA, ANDA, BLA, 510(k), and PMA submissions, along with guidelines related to CFR's, ICH, ISO 9001, ISO 13485, ISO 15198, and ISO 14971.• I collaborated with other students and worked on various projects related to project management, strategy development, and benefit-ratio assessments.I have completed my Bachelor's in Pharmacy with a CGPA of 3.6.• I developed knowledge related to chemical and biological drug development that involved theoretical background about various instruments used in pharmaceutical industries like HPLC, GC, and spectroscopy.• Performed practicals to determine RBC, WBC counts, dose alteration, and some theoretical information about ADME, mechanisms of action, and classifications of drugs.• Structural activity relationships and synthesis for drug formation. I also prepared tablets, granules, emulsions, and suspensions to treat specific diseases by understanding the quantity requirements of the APIs and excipients.• Enhanced proficiency in different documentation processes in the quality assurance and quality control fields. Learned methods for licensing in different regulatory bodies, pharmacovigilance, and jurisprudence.I am looking forward to working as an RA/QA specialist or in a laboratory where I can put my theoretical knowledge into practice and gain valuable experience.