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Company’s advantage is turn-key solutions and multiple expertise, adherence to the criteria of safety, efficiency, and risk minimization. This allows effectively apply innovative technologies, including biotechnology, taking into account health and safety standards.

 

The company staff includes experts with 15+ years of experience in the relevant field. The team was formed on the basis of years of cooperation with the best industry specialists, stable professional team plays the key role in the successful development of business and, moreover, is an additional factor in the reliability of business activity. For over 5 year period of hard work, the team has developed an algorithm of an individual approach to problem solving of each customer; acquired skills to find a unique solution to any, even the most difficult situation.

Mr. Amit Rajan

Technical Director R&D and Technology Transfer                  

 

Key responsibilities

  • Technology transfer leadership
  • R&D Regulatory
  • Leadership — corporate technical board to strategize, plan, direct and lead organization for sustainable organization growth through creation of strong regulatory and R&D strategies, product pipeline and identifying business opportunities. Management and technical teams for superior performance through spotting and positively influencing talents internally and externally, effectively partnering with cross-functional leadership and influencing business -driven strategies.
  • Scientific – directing the various units of the organization for sourcing, cost effective strategies, study protocol designs to assure regulatory adequacy and timely completion. Experience in gearing up drug substance manufacturing units and reviewing the compliance in accordance with ICH Q7A.

 

Key Project Experience

  • Transfer of technology of production of pharmaceutical products from site to site
  • Transfer of technology of production of pharmaceutical products from R&D lab to production site
  • Gearing the QMS of drug substance manufacturing units (non sterile and sterile) to be in compliance to ICH Q7 and EU/FDA guidance on drug substance manufacturing/Aseptic manufacturing.
  • Gearing the QMS of drug product manufacturing units to receive EU GMP/USFDA/TGA certification
  • Periodic audit of the manufacturing units in accordance with ICH Q7A, EU GMP (EudraLex Vol4), WHO Geneva etc. guidelines.
  • Executing inspections of the manufacturing units and Bioequivalence centres on behalf of Marketing companies based at EU, US, Canada and Australia.
  • Development of Generic drug products for registration in EU, Canada, Australia and South Africa

Ms Hasumati Rahalkar

Technical Director Regulatory

Key responsibilities

  • Regulatory leadership — lead and manage numerous health authorities interactions FDA, European authorities (MHRA, EDQM), WHO, other global health authorities (e.g., South Africa, Australia, Brazil, Canada, Eastern Europe, etc.) to assure on-time submissions / approvals of DMF, EDMF, CEP, ANDA. Participation in various proactive collaborations with health authorities to formulate efficient strategies to support sterile and non-sterile specific operations.
  • Establishment of Quality Documentation System for Regulatory Services / GMP approval
  • Ensure «Zero Accidents» in the Regulatory Services facility by following strict safety procedures and safety checks
  • Implementation & maintenance of quality management system
  • Development and Implementation of corrective & preventive actions

 

Key Project Experience

 More than 22 years of rich experience in Pharmaceutical Industry, cooperation with Glenmark Pharmaceuticals, Nicholas Piramal, Lupin Limited and Claris Lifescience.

  • Successful interaction with various regulatory authorities and preparation of regulatory strategies for new market entries.
  • End to end GMP, regulatory and business development activity covering strategy development, due diligence of dossier, in –license/out-license of dossiers, Submission Management to Health Authorities, GMP audits Personal meeting with Health Authorities and product market launch.

Mr. Amit Prajapati

Technical Director Biotech R&D & Technology Transfer

 

Key responsibilities

  • Leadership for Biotech products development and technology transfer
  • Identify appropriate resources needed and develop schedules to ensure timely completion of projects
  • Primary responsibility for defining, planning, tracking and managing the projects and leading a crossfunctional core team to deliver results

 

Key Project Experience

  • Validation Technology Manager in BioZEEN
  • Validation Services Manager in Bioture Labs Pvt.
  • Validation Specialist in PALL Life Sciences Ltd.
  • QC-Executive in Troikaa Pharmaceutical Ltd..
  • Technical in Vaccine R, Zydus Cadila Healthcare Ltd.
  • LRQA, Qualified QMS Auditor/Lead Auditor, FDA Approved Microbiologist

Dr. Gopakumar G. Nair

Chief of patenting department

Key responsibilities

  • Patent screening and analysis
  • Development of patenting strategy
  • Patenting

Key Project Experience

  • Dean of Institute of Intellectual Property Studies (IIPS) at Hyderabad, India. Presently also CEO of Patent Gurukul, reputed and well-known training centre for Patents.   Chairman of Gnanlex Hermeneutics Pvt. Ltd., a well-known LPO/KPO. Registered Patent & Trademark Agent and also Scientific Adviser to the Patent Office under Rule 103 of the Patents Rules, 2003.
  • D from National Chemical Laboratory (NCL), Pune, Law (LL.B) graduate from Mumbai University. IPR Committee Chairman of Indian Drug Manufacturers’ Association (IDMA).
  • 40 years in Pharma Industry as Director, Managing Director & Chairman of various public limited pharma companies, also served Industry Associations for more than 35 years in various capacities, latest as President of Indian Drug Manufacturers’ Association (IDMA), during 1999-2000. Editor and Editorial Board Member of various publications and journals, relating to pharma, biotech and chemicals, including IDMA Bulletin and INDIAN DRUGS.