ISHA'S GMP - Key Persons

Job Titles:

• Director API Synthesis & Technology Transfer

Myself Ph. D. in Organic Chemistry from Premiere Institute of Chemical Technology Mumbai and Business Management from Welingkar Institute Mumbai in 1994. Over 27 years Industrial experience in Chemical and Pharmacetical Industries in Indian and Multinational Companies of development, production , Projects and overseas marketing of phama Intermediates and APIS. Worked with joint projects at clinical Phase development and production of APis with Lundebeck Italy, Merck Germany etc. I lead the team for Intermediate and API manufacturing Plant Projects and successfully completed US FDA audit. Very well versed with all R&D techniques for devepoments of APis and Intermediates with taking care of regulatory and GMP requirements. We support our customers, with complete project management solutions which include but are not limited to GxP Auditing, Regulatory filings and solutions, Life cycle management, GMP compliance, IT Solutions for the Pharmaceutical & Biotechnology industry, Greenfield projects, Turnkey projects, Business development, Product development, and analytical solutions and services.

Job Titles:

• Chief Executive Officer

He holds a degree in Labor & Social Welfare and MBA, with more than 34 years of rich experience in the field of Human Resources & Industrial Relations, he has been associated with various FMCG, Pharmaceutical, Automobile & Real Estate Industries & has in-depth knowledge of managing critical business operations in various Industries. He has expertise in various crucial functions such as Strategic HR Planning, Organization Design & Development, Green Field Projects, Manpower Planning, Corporate Affairs, Business Process improvement, Operational excellence, Performance Management, Legal Compliances and all other HR Functions. Expertise Strategic HR Planning Organizational Design & Development

Job Titles:

• Director - Technical

Pankaj has over 18 years of combined experience in dealing with several Active Pharmaceutical Ingredients (APIs) and Finished dosage forms. He is completed his Chemical Engineering from Mumbai University & Project done on an Acid Effect on Liquid-Liquid Equilibrium with demonstration of separation methods. And Pharmaceutical management studies from IPER and Web Application programming from NIIT. Professional enhancements as Certified GMP auditor & Trainer and attended various trainings and conferences related to various GMP rules and regulations. He has experience in the Production & Projects, Regulatory Affairs, QA & QC functions and successfully submission and approval of the DMF's / CMC in CTD & eCTD formats for countries like EU, AU, SFDA, MedSafe, AIFA, MHRA, MFDS, FAMHP, HAS, TFDA, NMPA (China), PMDA etc. He has experience in interfacing with various global regulatory agencies and handled many audits from TGA, MFDS, PMDA, WHO-GMP (CDSCO) etc and other EU agencies. He is also extensively involved for business needs and attended many global trainings and seminars in his fields of expert. He worked with companies like Watson Pharma, Arch Pharmalabs, Fermenta Biotech Limited (Duphar Interfran Group). He has a hands-on role in the company's development, from generating the Business to designing and developing solution for regulatory and Pharma Industry.