Mr. SR Parthasarathy is brings over 50 years of experience in quality control, quality assurance and manufacturing domains. Having started his career as a chemist in 1969, he worked extensively and resigned as a Manager-QA in 1994 from Parke-Davis India Limited, an affiliate of erstwhile Warner Lambert, USA now merged with Pfizer. He had undergone training in Total Quality Management from NITIE, Mumbai and also underwent training on Statistical Quality Control from Indian Statistical Institute. At Parke-Davis he coordinated manufacturing activities with emphasis on Quality of over 10 contract manufacturers consisting of Oral Liquids, Tablets, Topical Preparations and Parenterals. During his career he has conducted several vendor and product performance audits. He has visited over 200 Intermediate, API & Formulation units and public testing labs and is presently functioning as a consultant for various Allopathic API & Formulation, Intermediate, Ayurvedic and Hoeopathic formulations and Food Manufacturers in the areas of Quality management and safety compliance. He is a consultant and Trainier for over 160 companies across the world and have delivered about 2500-3000 training programs.
As a third party auditor he assessed the quality competence of various companies in Oman, Spain, Australia, Netherlands, India, Various South East Asian Nations, West Africa, Brazil, China & Denmark. He also trained the regulatory authorities of Nepal on Pharmaceutical Quality Compliance. He is the promoter of GMP Pharma Consultants which is involved in GMP & GLP Training, Compliance audits, Preparation of Dossiers and Project Management. He is a trustee member of PECOS Charitable trust and is actively working for educating poor children particularly on Girl children's education and women empowerment.
Mr. Parasuram Dhulipalla has over 13 years progressive experince in the Clinical Research and pharmaceutical industry. He had coordinated several global audit programs on behalf of clients. He had Audited both Early & Late Phase Trials in Europe, Africa and Asia Pacific (APAC) regions.
His GCP Audit experience includes Early and Late Phase site audits, Investigator Site, Clinical Study Reports, Trial Master File, Protocol, database, Pharmacovigilance, Informed Consent, Contract Research Organization (CRO), and audits of Vendor and Systems. He had performed GCP audits in therapeutic areas including, but not restricted to: Cardiovascular, CNS, Endocrine, Gastrointestinal, Dermatology, Infectious Disease, Neurology, Oncology, Ophthalmology, Pulmonary and Rheumatology.
Mr. Tata Santosh has over 13 years of experince in the pharmaceutical industry. Having worked with organizations like IICT-Hyderabad, Apotex Inc, Jubilant Clinsys & Actimus Biosciences, he has pioneered in the areas of Bio-Analytical & Analytical Method Development & Validaiton, Clinical Drug Development & Pharmacokinetics. He can Manage and assess the overall progress of BA/BE studies. With good knowledge of GLP & GCP, CTD formats & CSR he is capable of providing key inputs for successful completion of BA/BE research projects. He had Developed & validated over a 200 LC-MS/MS and/or HPLC methods in various Biomatrices including NCE’s and has good Expertise on Quality Management System. He also trained the faculty of Birla Institute of Technology-Ranchi as part of the Quality Improvement Program organized by AICTE, India.
Dr. B. Nagamani is a doctoral candidate in Pharmaceutical Technology. Her Doctoral studies on isolation of novel amylase inhibitors [analogs of Tendamistat --- A molecule under Clincial trials for treatment of Diabetes] received good applaud from the Scientific Community. She is the topper during her Bachelors & Masters Program among all University Colleges. In her previous years of experience as a Professor of Pharmaceutical Technology, She has guided over a 25 Masters Program Candidates and published various papers in International Journals of repute. With her thorough knowledge on product formulation design and expertise on process technology, she leads the projects of Formulation Development.