Hire Dr. Pratikkumar D. Asari, a pharma consultant specializing in Clinical Studies, FDA Inspections and Medical Devices. See services offered, experience summary, and connect via apicule.
Based in: India
Willing to work in: Global
Consultant Type: Independent Consultant
Expertise summary: Dr. Pratikkumar D. Asari is a clinical pharmacologist and independent consultant supporting pharmaceutical companies, clinical research organizations, and medical device organizations. His expertise includes clinical development, clinical pharmacology, protocol design, Good Clinical Practice audits, regulatory filing support, clinical research inspection readiness, and CAPA follow-up. He holds an MD in Pharmacology and brings experience as a principal investigator, clinical research leader, and medical reviewer. His career includes roles with Accutest Research Laboratories, Watson Pharma, Alembic Pharmaceuticals, and Advanced MedTech Solutions. Through his consultancy work at KD Research Solution, he supports BA/BE studies, PK-PD studies, clinical trials, and medical device clinical evidence programs. He helps teams strengthen study documentation, oversee participant safety, assess clinical data, and prepare for regulatory inspections. - Show More
Dr. Pratikkumar supports CAPA activities arising from clinical research audits, inspections, and quality-system assessments. His experience includes CAPA support during clinical facility operations and follow-up within consultancy assignments. He helps research teams document actions addressing identified findings and coordinate follow-up across study personnel, quality teams, and external research partners.
Dr. Pratikkumar supports clinical development through research strategy, study feasibility review, and scientific and operational oversight. His experience includes clinical trials, BA/BE studies, clinical endpoint studies, and medical device investigations. He helps teams coordinate study planning, execution, monitoring, and reporting, drawing on his work with investigators, CROs, ethics committees, and clinical facilities.
Dr. Pratikkumar provides clinical pharmacology support for bioavailability, bioequivalence, and pharmacokinetic-pharmacodynamic studies. His experience as a principal investigator includes medical monitoring, clinical data interpretation, subject eligibility assessment, and adverse event review. He helps research teams assess participant safety and interpret study findings using his medical and pharmacology background.
Dr. Pratikkumar supports FDA inspection readiness for clinical research facilities and study operations. His experience includes inspection-readiness reviews, audit documentation preparation, and participation in USFDA and other international regulatory inspections. He helps teams review protocols, consent records, safety documentation, and study reports, and prepare responses and clarifications relating to study conduct.
Dr. Pratikkumar supports GCP through clinical research audits, quality oversight, SOP review, and professional training. His experience covers informed consent, investigational product accountability, delegation of responsibilities, subject protection, and study record retention. He helps clinical teams assess study practices, identify documentation gaps, and follow up on findings arising from audits and quality assessments.
Dr. Pratikkumar supports protocol development and review for clinical trials, BA/BE studies, and PK-PD studies. His work includes reviewing study feasibility, amendments, informed consent forms, case report forms, and investigator brochures. He helps teams align study documentation with research objectives, operational requirements, and participant safety considerations.
Dr. Pratikkumar supports regulatory filing through preparation and review of clinical and medical documentation for CTD/eCTD submissions. His experience includes clinical study reports, safety narratives, ethics committee submissions, and medical device clinical evaluation reports. He helps teams organize clinical evidence and review supporting documentation for regulatory approval activities.
