Isha's GMP Consultancy, Chennai - 600 014, India Monday - Saturday 08:00-19:00 +91 9976491578

Core Team

Mr. Sanjay Kumar Mandal

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
  • Staff Welfare Activities
  • Budgeting/ Resource Forecasting
  • Union Negotiations/Mediation
  • Change Management
  • Green Field Projects
  • HR Best Practices
  • Succession Planning
  • Performance Management
  • OD Intervention
  • Change Management
  • Compensation & Payroll
  • Policies/ Procedures/ MIS
  • Life Cycle management
  • Corporate Social Responsibility (CSR)
  • Corporate Affairs
  • Business Process Improvement
  • Operational excellence.
  • Relationship Management
Worked in leading companies like Sovereign Pharma Pvt Ltd, (A joint venture of Poonawalla Group & Schott-Kaisha Group), Oiles India Pvt Ltd (A Group Company of OILES Corporation, Japanese MNC), Rajasthan Prime Steel P. C. Pvt.Ltd., (A Group Company of HONDA Car, Japanese MNC), Kumar Group of Industries , Dabur India Ltd , East India Udyog Ltd. He is Founder CEO of M/s.Ashtochem Enterprises, M/s.Daman Aqua and M/s.Chandra Associates.

N. Kamalakar Rao, M.Pharma

Principal consultant formulation development & technology transfer
Master of Pharmacy (Drug formulation & Technology) with a GATE 88 score from University College of Pharmaceutical Sciences, Kakatiya University, Warangal, India passed out in the year 1990. Over 30 years of versatile, industrial experience in areas of the pharmaceutical preformulation, formulation and process development and technology transfer of all oral dosage forms, External and parenteral dosage forms with leading pharmaceutical companies TTK, Parke-Davis, Strides, Banner Pharma caps, Unichem, Promed, Suven and Swiss Garnier generic pharmaceutical companies. Experienced in the Literature and patent search, Quality by Design, pre-formulation, formulation and process development, stability studies and interpretation of development data and troubleshooting, clinical supplies formulation for NCE and generic products with Q1, Q2, Q3 mapping with RLD, scale up of immediate release tablets (Including low dose), delayed release, extended release tablets, film coated, sugar coated, Bilayer tablets, soft and hard gelatin capsules, MUPS, NDDS, oral liquids, Lozenges, suspensions, chewing gums, parenteral/ophthalmic and Topical/External application formulations. During my career, developed products for regulated markets bioequivalent to Reference product for Solid Orals and Ophthalmic formulations and apart from for ROW and domestic markets more than 100 product developed and commercialized successfully.

R. Vaidhyanathan, B.COM, PGDFM, ACS.

Director Finance
More than 30 years of experience in Finance and Accounts Management as at various levels and handled various financial projects. During his 30 years in public accounting & financial, he experienced all facets of the services provided by participating in audits, tax preparations of all entity types, sales tax filings, payroll preparation along with monthly, quarterly and annual filings, as well as, monthly compilations.
As a controller in the private sector, he had the opportunity to oversee and manage staff in all areas related to the accounts & financial performance of the organizations. In addition, he was an integral part in development and evaluation of budgets, forecasts, KPI’s and cash flow forecasting models and managed the outside relationships with auditors, banking and legal counsel. He has significant experience in a wide range of businesses from construction to distribution and specializes in developing tools to evaluate and enhance the performance of businesses. His expertise has an emphasis on tax planning and preparation for corporations, partnerships and individuals., he has worked with small, medium & MNC and start-up businesses, giving him the knowledge and experience to oversee the industry helping clients with strategic business planning for future success and growth. Also continues to improve upon accounting policies and procedures as well as the development and delivery of training and enhanced financial reporting. He leads the team of outsourced online bookkeepers, supervisors and financial controllers to continually develop systems of communication for clients and their accountants using the most innovative solutions in virtual accounting. In addition, he works closely with clients to develop accounts & financial procedures to streamline and organize clients’ virtual accounting & financial services.

R.Senthil Kumar., M.Sc., D.I.S.M.,MBA.

Director GxP Operations
Having 25 years of versatile industrial experience in MNC and Indian Pharma, handle Project Management, Audits & Compliance Management, Regulatory Affairs & GxP Training with rich experience of various pharmaceutical drug substance & drug products (API/KSM & Formulation) of Sterile and non-sterile ranges like Cephalosporin, Beta-Lactam, Hormone , Oncology and general category with excellent exposure in setting up of QMS, Policies, Guidelines & Project Management and sound experience of all regulatory requirements like USFDA, MHRA, MCC, MCAZ, EU GMP, TGA, ANVISA, INVIMA, WHO GMP (Geneva) and other International regulatory bodies and Result oriented association. Actively participating MHRA GMP & GDP Symposium, London West, United Kingdom.
He is driving force of Senior, General and Executive Management experience in the pharmaceutical industries in various quality, projects, manufacturing, validation, and consulting roles worked Aurobindo Pharma, Torrent Pharma, Glaxo SmithKline (GSK), MSN Labs and MERCK. His vision is to provide industry with end to end solutions, practical, cost-effective solutions to regulatory challenges and is recognized as a leading international harmonized GMP consultant.

Pankaj P. Zambare

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.

Working on both sides, for Industry and as a consultant, it drove him to take both roles and serve industry for its greater cause with efficient and knowledge base services. His passion to operate, organize and communicate has been the driving force behind successful roles in both executive leadership and business ownership with technical expertise over the years.

Dr. Ramesh Natekar

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.