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Dr. Hardeep Wadhwa is a seasoned pharmaceutical expert with a strong track record of driving innovation and growth. As Director of Pharmassist International Consultants, he mentors and monitors international pharmaceutical research projects, providing strategic guidance on formulation development, patent analysis, and regulatory affairs. With over 20 years of experience in product development, Dr. Wadhwa has successfully led the development of numerous projects, including parenteral and oral solid dosage forms, and has developed over 100 formulations, including 11 novel delivery systems. He holds a Ph.D. in Pharmaceutics from Panjab University and has published research in various fields of pharmaceutical science.

Experience

    • Director
      • Feb 2015 - Present
      • India

      As Director of Pharmassist International Consultants, I mentor and monitor Pharmaceutical Research projects for International companies of repute. I work as an extended R&D arm for my clients, specifically providing the following services:- Finding suitable partners for Formulation Development experienced in NDDS, Patents & Regulatory affairs.- Mentoring Product development to deliver a stable, Bio-equivalent, Patent non-infringing, scalable and cost effective formulation, also providing innovative, patentable ideas for NDDSs.- Monitoring Product development at all stages to ensure that the milestones are completed as per the agreed activities, timelines & budget, at the same time ensuring data integrity and confidentiality of the project.- Finding suitable partners for Contract Manufacturing and Bio-equivalence studies of Pharmaceutical Formulations in India.- Contributing towards API sourcing from India and Drug master file review to ensure the suitability of API vendor.

  • Medefil, Inc.
    • Chandigarh, India
    • Advisor & Consultant - Pharmaceutical Development
      • Nov 2018 - Sep 2020
      • Chandigarh, India

      Led the successful development of 4 parenteral projects for US based Medefil, Inc. at an Indian pharmaceutical company.

  • Chanelle Pharma
    • Loughrea, County Galway, Ireland
    • Consultant - Pharmaceutical Development
      • Feb 2015 - Jan 2020
      • Loughrea, County Galway, Ireland

      Mentored and monitored the development of more than 10 projects of oral solid dosage forms, co-ordinating between Chanelle R&D department and different research labs and companies across India.

  • Ind Swift
    • Chandigarh Area, India
    • Head of Research & Development
      • Dec 1994 - Jan 2015
      • Chandigarh Area, India

      As R&D Head of Ind-Swift, I took care of complete Product development including Intellectual property evaluation, Formulation Development, Analytical Development, Packing development, Stability studies, Process optimization, Scale up, Tech transfers, Validations, BE studies and Regulatory affairs. Developed more than 100 formulations including 11 NDDS, some of which became the star products of Ind- Swift Group with International patents. These included:- Clarithromycin Modified release tablet - The related barrier patents and technical problems of poor solubility, bioavailability and stability of the drug were overcome by making a citrate salt of the basic drug and using it in Extended release tablet. US , EU and Indian patents were granted for the same. The developed product is now marketed by most of the major generic companies of Europe.- Clarithromycin Coated granules - Developed Taste masked granules of Clarithromycin - a leading macrolide antibiotic using complexation by a polymer followed by Wurster Fluidised bed coating technology using another polymer. This became a very successful commercial product of the company.- Developed a patented process for ‘Taste masked, directly compressible and fast dissolving Fexofenadine-Carbomer complex for use in its mouth dissolving/ dispersible/ chewable/ conventional solid dosage forms’. US, European and PCT patents published for the same. Patents granted for Europe, Australia, Mexico, Algeria, Tunisia and India.

Education

  • 1990 - 1994
    Panjab University
    Ph.D., Pharmaceutics
  • 1977 - 1982
    Panjab University
    B.Pharm., M.Pharm., Pharmaceutics

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