Isha's GMP Consultancy, Chennai - 600 014, India
Monday - Saturday 08:00-19:00
+91 9976491578
Our Advisory Team
Dr. Merugu Raju., M.Pharma., Ph.d.
Principal consultant formulation development & technology transfer
Having an experience of over 25 years in the Pharmaceutical Industry. Designing and developing oral drug delivery systems including NDDS Catering to the needs of the developed markets. Worked MEDLEY PHARMACEUTICALS LTD, MSN Laboratories Ltd, Medreich Laboratories Limited, Ipca Laboratories Ltd, Macleods Pharmaceuticals Ltd.
Dr. Rajendraprabhu., Ph.D., Biomedical Science
Sr. Consultant – Biotechnology projects
Having and experience of over 35 years in the immunobiologicals field and developed anti gas gangrene serum, anti snake venom serum (ASVS) – Indian and African snake venom, Diphtheria, Pertussis and Tetanus vaccine (DPT), ARS, ADS, ATS, and scorpion venom anti serum. He worked in King institute preventive medicine, Mediclone research centre, Blue whale biological ltd. He developed anti-cancer drug from snake venom components and antigen purification, RIA and ELISA
Mr. Sudesh Kumar H N.
Sr. Consultant – HVAC & Clean room solutions
He is experienced professional with cumulative experience of 30 years in HVAC & Clean room solutions and he has been done many projects with BSL-2 at Indian Institute of Science, Strand Life Sciences Pvt. Ltd, S3V Vascular Technologies, ARPL (Apotex), JubilentBiosys (Two Projects), RANBAXY Nigeria Africa, Nigerian German Chemicals (NGC), STRIDES VITAL, Karnataka Antibiotic Pharmaceutical Ltd., AFDIL (Anglo French Drug Industries), Reich India, SEQUENT LAB, Relisys Medical Devices Ltd, Strides Arcolab Ltd, SOLECTRON CENTUM, MAKINO India Pvt Ltd, Plansee India High Performance Materials Pvt.Ltd, Valdel Advanced Technologies Pvt. Ltd, IRIS INDIA Inc, Swapna Pharma, Zakinl Biotech, Sreekar Pharma, Rajsons Pharma, Meyer Organic Pvt.Ltd, Kanachur Hospital, HCG Curie Centre of Oncology, Hi – Tech Kidney Stone Hospital, BGS Appolo Hospital
Sanjay Shukre., B.E. (Electrical), FIETE, MIE, C.Engg.
Sr. Consultant – Projects Management
He is having 30 years rich experience in pharma industry in the field of electrical, HCAC, Utilities and Projects. Worked EDS Pharma, Republic Of Congo (Central Africa) location OYO Brazzaville, Congo for setting up Formulation facility for Tablet, Capsule and Liquid., JCS Humanity, Tbilisi, Georgia. project location for Tbilisi, Georgia for setting up Formulation facility, Zim Laboratories Ltd. Kalmeshwar, Ushma Technologies Pvt. Ltd. Pithampur, UTPL is setting up a new plant for Anti Cancer for Tablet, Capsule, and vial, Paras Pharmaceuticals Ltd. Baddi, M/s. Plethico Pharmaceuticals Ltd. Indore, Man Industries (India) Ltd., Pithampur, and Kusum Ingots & Alloys Ltd. Pithampur, Distt. Dhar
Exposure in conceptualization of new projects. Dealing with Architects, Contractors, and Government bodies. Negotiation with contractors and site selection and land procurement and to facilities construction activities, developing Project schedule, sequencing, updating, maintaining and managing Contractors and Vendors to the schedule, plant maintenance Practices and procedures and bench marking of maintenance / Expenses. Pharma utilities like Boilers, Chillers, HVAC, BMS SYSTEM, Air Compressors, purified Water plants, WFI Plants, Diesel Gen sets, and its Synchronization system, Design of electrical panels, and ETP, to comply USFDA/ MHRA/ TGA/ WHO guidelines
Samir A. Vasavada, M.Pharma
Sr. Consultant – Pharma Operations
Pharmacist with 35 years experience
Pharma Production / Supply Chain / Techno-Commercial / Clinical Research / Tech Transfer / Pkg Development
Has experience of over 35 years in the pharmaceutical industry in different categories of drugs and molecules Worked with reputed Pharma MNCs in various capacities. Has worked as Associate Director – Manufacturing Science and Technology & Packaging and Label Management in ABBOTT INDIA LTD, Worked as Head –EXTERNAL MANUFACTURING, Manager Planning in KNOLL PHARMACEUTICALS LTD., A German, healthcare company devoted to the discovery, development, manufacture and marketing of pharmaceutical in 90 countries worldwide, BOOTS PHARMACEUTICALS LTD.
One of the best known retail names in the UK, providing health, beauty and OTC products and advice that enhances personal wellbeing. Worked with PFIZER LTD, Pfizer Inc discovers, develops, manufactures, and markets leading prescription medicines for humans and animals and many of the world’s best-known consumer brands.
Dr. Sunil Avdhut Kanvinde., M. Pharm, Ph.D. (Tech), D.I.M., LL.B.
Sr. Consultant - Life Science Management
Pharmacist with 35 years experience
Certificate in German Language from Sr. Consultant
Having and experience of over 35 years in the pharmaceutical sector for various category of drug and molecules with MNC company experience. He worked in German Remedies Limited, Manager – Tablet Production, Manufacture of various Dosage Forms, E. Merck (India) Limited, Production Manager Pharma, Plant management, Tablets and Ampoules, Engineering and Warehouse with work force of 250 employees, Novartis India Limited, Head – Production – Formulations Outsourcing, Contract Manufacturing – various dosage forms, Strategy, evaluation, Selection, New launches, Tech Transfer, Audit compliance, performance measurement, commercial and legal, Sandoz Private Limited, DGM – PRODUCTION Outsourcing, Manufacturing and.
Packaging development and sourcing for global Sandoz affiliates, Ranbaxy Laboratories Limited, Director Pharma Manufacturing, Head for Two sites manufacturing Oral Solids –Tablets and Capsules, Sterile Injections and Dry powders – Cephalosporin, Penicillin and Penems and soft gels for regulated and emerging markets, steering committee member Product development and Tech transfer, Quality Compliance and Audits – Group member, Apotex Research Private Limited, Sr Manager – New Product Launch and Packaging Development, Manufacturing for New Product Launches for regulated markets and Packaging Development, Pfizer Limited, Senior Manager Contract Manufacturing, Global Supply, CMO for Finished Dosage Forms, manufacturing and technology, quality compliance, deliveries, Commercial and legal, Acme Generics, General Manager Technical, Compliance and Training, readiness for EU GMP audit in terms of Quality and Manufacturing systems, Sri Krishna Pharmaceuticals Limited, VP Operations, Head of Formulation manufacturing and Technology transfer for regulated markets, Immacule Life Sciences, VP-Project Management, Project management for sterile liquids and Lyophilized injections for regulated markets.
Dr. Yuvaraj (Pharm)., Ph.D., D.Sc
Principal consultant – Clinical Research
Dr.Yuvaraj qualifications in medicinal chemistry in PG, research of doctarte areas in preclinical and clinical cancer mechanism newer molecules in pharmacology division, include being a Certified Laboratory Assessor (Lead Assessor) on the CSI drug discovery network channel in clinical groups. Ministry of Science and Technology, Government of India since 2006 for ISO 17025:2005; a certified quality systems auditor for ISO 9001:2008, ISO 15189, ISO 17025 certified auditor for Information Security Management System (ISMS) ISO 27001:2005. He has vast experience of auditing / monitoring preclinical studies, auditing/monitoring bioequivalence studies (including studies with PK in patients, bioequivalence studies with clinical end‐points). He has experience of auditing clinical studies (Phase I to Phase III) in various therapeutic areas like oncology, endocrinology, respiratory, CNS etc.
Dr Yuvaraj has conducted audits in different geographical locations in India, africa, Canada and Europe. Dr Yuva has been awarded as a Chartered Scientist (C.Sci.) by the Science Council. In his capacity as both a Quality Unit leader and as auditor he has been responsible for audits & systems development, pre‐approval audits, development of compliance policies and procedures for product development. Dr.Yuva has experience of successfully facing inspections from various Regulatory Authorities like DCG (I), WHO, ANVISA, EMA, MedSafe, USFDA etc.
Dr Yuva is a speaker at various workshops, seminars and conferences.
Professional Membership in various bodies.
N. Murugesan
Sr. Consultant Projects & Engineering
Worked M/s. Swiss grainier at Sikkim as ‘VP-Operation (Plant Head)’ responsible for setting up Rs 500 Mn Green Field Project for OSD &Topical Solutions, worked M/s. Sarvotham Care, Baddi as ‘GM-Project & Engg’, worked Vaccine Mfg Co., Chennai as Head-Maintenance and Engineering. Green Field Project for Vaccine Mfg (Rs 400 Mn), worked M/s. Shelys Pharmaceuticals, Tanzania as Head – Engineering responsible for executing the US$11 Mn projects for (Green Field) Solid Dosage for Tablets, Capsules, Liquid Orals, and Dry Powders including Penicillin Products.(OSD >2.5 Bn/month for one shift operations, worked M/s. SRP Envirosystems Pvt. Ltd., Hyderabad as General Manager – Projects, worked M/s.Apex Engineering Services, Nasik as General Manager Planning, Executing HVAC & Modular Clean Room projects for API, Pharma / Electronics industries within the specified time and budget including commissioning and validation, worked M/s. Global Pharmatech Pvt. Ltd., Hosur as General Manager – Tech Involved in Planning, Procurement, execution, commissioning, validation of Sterile Injectable plant (Greenfield-Rs 85 Mn) for Small and Large Volume Injectable, worked with Fine Chemicals Nigeria Ltd., Lagos, Nigeria as Project/Maintenance Manager.
Mr. Vijay Bhusare
GMP Sr. Consultant
Vijay Bhusare GMP Consultant Vijay Bhusare is a GMP consultant in the GMP Compliance and Practices for pharmaceutical manufacturing organizations; over 30 years of experience in pharmaceutical quality management. The approach is to determine, implement the proper technical and quality strategy for the situation at hand. Well experienced in various dosage forms and API industries. Proficient team leader in internal and supplier quality auditing. Having good experienced in interactions with the WHO, US FDA, EU, MHRA, PICs and other worldwide regulatory agencies inspections. I can guided, train and develop the teams in implementation of internal quality standards leading to successful regulatory inspection.
• General Manager – Head Quality at Centaur Pharmaceuticals Ltd.
• Site Head Quality control / Assurance at IPCA Laboratories Ltd;
• Worked with Indian top ten organization as t Lupin Ltd; Wockhardt Ltd, Ranbaxy Ltd, Sun Pharma Ltd and Strides Arco Lab Ltd in various capacities as Quality Management Representative.
• Very good experience of working in international atmosphere like Middle East and South East Asian countries as Quality Head and specially trained by Shimadzu Co; Kyoto, Japan
DR. Mithilesh Narendra Trivedi., Ph. D. (Organic Chemistry)
Sr. Consultant GxP Operations
U.D.C.T. (Presently known as I.C.T.), University of Mumbai
Dissertation: Synthesis of Pharmacologically Active Compounds.
Technically astute & diligent Professional with an experience of over 38 years in the area of Research & Development / Production / Operation / Quality Control & Quality Assurance / Training in the Chemicals, Fine Chemicals, Bulk Drugs (API) and Formulation Industries.
Expertise in product development, process optimization & control, standardizing production norms & chemical lab practices.
Proficient in supplier technical assurance, vendor audits & qualification. Ability to take challenges of identifying & auditing the suitable Outsourcing facilities for supply of quality & quantity of API, Intermediates & formulations in defined time frame with cost efficiency. Audited more than 20 manufacturing sites in China & number of manufacturing sites in India for the same.
Demonstrated hands on conducting chemical; instrumental and microbiological analysis. Experience in Sterility Pyrogen including BET (LAL Test) and Toxicity Testing. Ensured compliance of various quality measures by maintenance of appropriate requisite documentation/ records.
Worked BDH Industries Ltd, Themis Medicare Ltd, OmniActive Health Technologies Ltd, Calyx Chemicals & Pharmaceuticals Pvt. Ltd, Kusum Healthcare Pvt. Ltd, Rusan Pharma Ltd, Ajanta Pharma Ltd, Cachet Pharmaceuticals, Avik Pharmaceutical Ltd and Indoco Remedies Ltd.
SIGNIFICANT ACCOMPLISHMENTS
- Awarded Sr. Research Fellowship by Department of Science and Technology, Government of India.
- Elected as Council Member of Indian Pharmaceutical Association (IPA), Maharashtra State Branch, Mumbai.
- Vice Chairman for Technical Sub – Committee and Committee Member of R & D sub Committee of IDMA
- Elected as Founder President of IPA, Bhiwadi Local Branch.
- Awarded number of certificates for the Appreciation effort & work by Various Departments of Uzbekistan Government.
Ms. Prema - M.Pharm (Gold Medalist)
GMP Consultant
Prema is a (Gold Medalist – M.pharm) GMP Quality Operations consultant in the GMP compliance and practices for pharmaceutical manufacturing organizations. The approach is to determine, implement the proper technical and quality strategy for the situation at hand. Well experienced in various dosage forms. Proficient team leader in internal and supplier quality auditing. Having good experience in interactions with the WHO, USFDA, MHRA, ANVISA, PICs and other worldwide regulatory agencies inspections. She can guide, train and develop the teams in implementation of internal quality standards leading to successful regulatory inspection.
Worked at Navamin Pharmaceuticals, Softgel Healthcare, Saimirra Innopharm, Archimedes Healthcare and Intermed.
Worked at Navamin Pharmaceuticals, Softgel Healthcare, Saimirra Innopharm, Archimedes Healthcare and Intermed.