Ph.D. in Pharmacokinetics of anti-psychotic drugs from University of Saskatchewan, Canada. Total 24 years experience in Pharma Research field while acting as Head and Senior Clinical Reviewer of the New Drug Application of Health Canada Ottawa. (Canadian FDA) for 7years, as a Director of Bio-pharmaceuticals of Bio-vail CRO, Toronto over 4 years and also a Research Consultant for more than 3 years. Successfully Designed, reviewed and managed more than 820 BE & Clinical studies; over 90 publication in refereed journals.
Masters in Analytical Instrumentation from Jiwaji University, Madhya Pradesh, India and pursuing Ph.D. in bio-analytical chemistry using LC-MS/MS from kachchh university, Gujarat, India.
Over 14 years of clinical research experience gained while working for companies such as Lambda Therapeutic Research, Torrent Research Centre, Aurobindo’s Research, GVK Bio-sciences and Veeda CRO and handle > 300 molecules and >775 BABE & few Phase-1 studies.
Key player in setting up & running CRO’s like GVK Bio-science and Veeda CRO. Successfully faced more than 350 clients/sponsor’s inspection & major regulatory audits. - USFDA-6, MHRA-3, WHO-4, ANVISA-4, , AGES-1, DCGI-4 & ISO:9001:14001-1.
>31 International research publication accepted by various international journals like RCM, JCB, JPBA, BM & GCS etc.
External examiner / co-guide, invited speaker, reviewer, organizing committee member & advisory board member for various International organization & Institute, and as a global bioanalytical expert actively contributing to global bio-analysis consortium on harmonization of Bioanalytical guideline. (A1, A6 & A9).
Master in veterinary science (veterinary Pathology) from Anand Agricultural University, Anand. More than 17 years experience in Animal Breeding, regulatory toxicology, model development and efficacy and quality assurances studies; while working with Jai Research Foundation, RCC Laboratory India Pvt. Ltd. and Cadila Pharmaceuticals Ltd. successfully completed more than 1500 toxicology and efficacy studies in various therapeutic area.
Ph.D. (Analytical Chemistry) from VNSA University, Surat; MS in Analytical Chemistry from Coventry University, UK; Master of Science (Applied Chemistry) from M.S. university, Gujarat, India. Over more than 10 years experience gained while working with Bio-arc Research Solution – Alembic, Macleod Pharma and Rajsha Aromatic Ltd. The main expertise is in method development and validation of different therapeutic drug in various matrixes (Plasma, Serum and Blood) on LC-MS/MS instrument as per the international guidelines..
M.Pharm from Gujarat University, Ahmadabad. More than 7 years of experience for conducting different types of bio-studies like Bio-equivalence, Drug-Drug interaction, Food effect and Pharmacokinetic studies as well as Glucose clamp, experimental studies and Phase-1 and 2 clinical trial and studies.
MBBS from Medical Graduate College; Jamnagar. Over 6 years experience gained in BE and Clinical trial while working with Accutest, Lambda Research Therapeutics, Synchron research, GVK Bio-science.
M. Pharm (Pharmacology) from Dr. M.G.R. Medical University, Chennai; MBA from ICFAI University. Over 10 years experience in QA and sound knowledge of non-clinical, BABE, clinical trial, statistical analysis, quality assurance and international regulatory affairs. Successfully faced major regulatory audits like- USFDA-3, MHRA-3, WHO-3, ANVISA-4, MCC-3, DCGI-3 & ISO-1.
MBBS from RNT Medical College, Udaipur. Over 6 years experience gained while working with Kendle (Now- INC Research) and Clinirx.
M.B.B.S, M.D with more than 2 years of experience for conducting different types of bio-studies like Bioequivalence study, Drug-Drug interaction study, Food effect studies and Pharmacokinetic studies
M.Phil (Statistics) from Gujarat University. Over total 5 years experience with software expertise on SAS, Win-Nonlin, Oracle Clinical, ClinOne, SPSS and IN-STAT while conducting different types of statistical analysis like Cancer clinical trial, Toxicity studies (FDA - Vaccine) and BABE.
M.Sc. in Medical Sociology from Chennai University and PGDCRA from AIPT, Kolkata. Over total 4 years of experience in medical writing. Preparation of CSR and CTD as per regulatory (ANDA, MHRA, WHO& ROW) submission, preparation of modules, summary report, Bio-equivalence trial information form coding sheet and internal SOPs.
M.Sc. in Clinical Research from Canfield University and Post Graduation Diploma in Clinical Research Management, at ICRI Mumbai. Over 20 months experience in marketing with good executive and interpersonal relationship skill with ability to build network of professionals. Detail oriented with excellent presentation skill and ability to manage competing priorities.