Mr. Vinayak Mhatre


  • Qualification: M.Sc in Analytical Chemistry by research from Mumbai University, Diploma in Drugs Regulatory Affairs
  • Worked in companies: Cipla Ltd, Watson Pharma Pvt Ltd, FDC Ltd (includes API and Formulations like OSD, Ophthalmic, ORS, Topical)
  • Worked in departments: Quality Control and Quality Assurance and very close support to Regulatory cell in submissions and queries handling.
  • Key skills: Good Documentation Practices, Good investigation skills in events like OOS, OOT, Deviations, Complaints, analytical incidences, Documentation involved in SMF, VMP, products recall / complaints, self inspection, Good Training and Co-ordination skills.
  • Audit Faced: USFDA (12), MHRA (15), WHO Geneva (4), IMB (2), EDQM (1), TGA (5), MCC (4), PICS (1)
  • Training given on various technical topics as well as on administration / communication skills
  • Training undergone: Auditors training (3 days course), attended many workshops in India on technical aspects like Stability study, CAPA, Investigations, Training on Chromatography in Singapore at Shimadzu and Agilent.
Dr.Manjusha Rajarshi


  • Academic Qualifications:
    • Masters’ Degree in Pharmaceutical Sciences, (University of Mumbai)
    • Doctor of Philosophy – (Pharmacology) (University of A.M. Kolkata)
    • Diploma in IPR- Patents, Trademarks and Copyright (Bioinformatics Institute of India)
    • Basic statistical analyses, advance statistical courses from CMC, Vellore
    • Currently pursuing the course in Public Health (elective specialization NONCOMMUNICABLE
      DISEASES) at Public Health Foundation of India, New Delhi
  • Work Experience:More than 20 years in the pharmaceutical industry (various companies –Serdia, Bayer, Aventis Pasteur, Unichem, B. Braun);
    Career began in sales and marketing department as a “Management Trainee”.
    Various career moves from training department, medical department, clinical operations and regulatory affairs and medical affairs.
  • Therapeutic areas handled:
    • cardiology, diabetology and metabolism, venous diseases, neuro-psychiatry, vaccines and other internal medicinal therapies.
    • Publication published on behalf of the employers: more than 25; majority in international journals such as IJCP, American Journal of Cardiovascular Drugs, Neurology, International Journal of Cardiology, Diabetes Research etc.
  • Job Responsibilities Held:
    • Responsible for domestic and international clinical studies
    • Regulatory affairs
    • Patents and Trademark issues
    • Pharmacovigilance
    • Biostatistics and statistical analyses
    • Medical writing and publications
    • Medical Affairs and information services
    • Doctor contacts, opinion leaders’ contacts and contacts with major governmental and non-governmental institutions (Cardiologists, Diabetologists, internists, neurologists, psychiatrists etc.)
  • Membership and affiliations:
    • Pharmacy Council of India (PCI), registration number 1988/ 3080
    • Indian Society of Clinical Research (ISCR), life member
    • Indian Association for Statistics in Clinical Trial, Life member
  • Teaching assignments:
    • Module developer with Academy of Clinical Excellence
      Topics covered Regulatory Module; teaching assignments Indian, US, European, Australian and Japanease Guidelines (visiting faculty)
    • Module developer with MUHS, for M.Sc in Clinical Research
      Topics covered Regulatory and Ethical considerations; teaching assignments with MUHS and also examiner and moderator for M.Sc.Part II
  • Visiting faculty:
    SVKM’s NMIMS University, School of Pharmacy and technology management; subject covered “Regulatory, Compliance and applied ethics”.