MEDICAL AFFAIRS
For your Clinical Development and Pharmacovigilance Needs
We decrease the time and cost required for drug development using our knowledge, skills and expertise, by using qualified vendors operating under a strict regulatory and quality compliant environment with the supervision of processes and documents by an established Quality Monitoring System
We help in the Clinical development of small and large molecules, by providing support in the areas of Clinical/Non-clinical drug development for Generic and novel drug molecules, and Pharmacovigilance to our customers.
From ideation for developing drugs with new technologies, to study conduct performed by pre-qualified vendors and eventual submission of the dossier including meetings with drug regulators, when required, we serve as the body and soul of all our customers.
Shashidhar has over two decades of experience working with multiple industries like Pharmaceuticals, Telecom, Banking & Insurance. Before joining Arcolab, Shashidhar was the Director of Agnus Capital where he was responsible for handling Business, Operations, Sales and Distribution for India and key international markets – Mexico, MENA, Africa & Europe for a leading Medical device company, Skanray. He was AVP of Mylan– Business & Operations for Europe, based out of Poland. Prior to this, he was with Aspen Pharmacare, based in Latin America, spearheading market expansion and growth for Andes Region and in Mauritius as COO, setting up and leading Global Supply Chain, Distribution and Business Transition for Global Brands.
Dr. Gopal has over 30 years of industrial & academic experience. He worked in USA for nearly 15 years with American Cyanamid & Wyeth Research, before returning to India as President & CSO of Lotus La, a CRO. He was the co-founder of Semler Research Canter & served as President & CEO for nearly 3 years, before he started his consulting firm, Dakshah Biosciences. His experience also, involves working with Tenshi Life Sciences & Advinus Therapeutics. He has been involved in development of New Chemical Entities and Generic molecules during his career and has worked extensively in the area of Clinical & non-clinical research.
Debarati leads the IP and patent strategies across group companies. She provides support in areas of API, finished dosage forms, parenteral, biologics & consumer health products by providing them with relevant advice regarding their IP. In 18 years of her career in the pharma industry, she has spearheaded many differentiated business-tech strategies across various markets. She has worked with various reputed brands & pharma companies like Mylan, GSK and IPCA in her career.
Mayank is a CA, MBA and a certified Six Sigma Green Belt. He brings more than 16 years of experience with national and international companies. He has worked in diverse fields of finance, in both service as well as manufacturing companies, having expertise in Business Finance (Commercial), FP&A and cash management. He has worked on controllership, vendor management, business planning, treasury and budgeting. Prior to Arcolab, he has worked with companies like Mahindra, FedEx, Aviva, Suzlon, Tata Capital, Bajaj, Graphite and PwC.
Sriram has 22+ years of experience within Finance function and is heading the Project Management and Biz Transformation office (PMO) for Arcolab. He has worked across diversified sectors including service sector like audit firms & software and manufacturing sector like pharmaceuticals & engineering, in various leadership roles across India, US & Asia-Pacific with companies like Ernst & Young, Oracle Software & Kirloskar Electric etc.
Balakrishnan currently heads the Information Technology function of Arcolab. He has 25+ years of IT and digital leadership in pharma and life sciences Industry. Bala has been part of the Information Technology journey of the group companies and has played a key role in the transformation initiatives to digitize manufacturing, laboratory and R&D processes. Prior to joining the group, Bala has worked in Cordell and Yuken, India.
Munish is responsible for crucial areas of Computer System Validations & IT QA. He looks after IT compliance in Enterprise IT Systems like SAP, MES, Track Wise & LIMS. In addition, he ensures digital compliance in manufacturing equipment & analytical instruments like BMS, CDMS for Manufacturing, R&D and corporate set-ups. He holds 25 years of experience comprising mainstream IT systems, Validations & IT QA in pharmaceutical and has worked with companies like Sun Pharma and Ranbaxy Laboratories.
Nikhil has 22+ years of experience in Talent Acquisition & heads the Talent Acquisition and Employer Branding for Arcolab, globally.
He has worked across diversified sectors like Pharmaceuticals, Telecommunications & FMCG. He has been into various leadership talent acquisition roles across India, North America and Asia-Pacific with companies like Jubilant Life Sciences, Telenor, Aircel, ABC Consultants & Pacific Century Cyber Works.
Rukmini brings over 20+ years of rich experience in business partnering, Performance and Rewards, Talent Management, Capability Development, Diversity & Inclusion and Change & Transformation in diversified sectors including FMCG, Healthcare, Beverage, Retail and Consulting. She has experience in conceptualizing and implementing Talent Management, D&I. Her core expertise is in building talent, learning & culture strategy and framework, processes and tools that enable the business to identify, build and sustain its talent pipeline.
Kalpesh is currently part of the Arcolab leadership team, leading the Performance and Rewards practice. Kalpesh, in his overall 16 years of experience, has led several teams working on a variety of Human Resources assignments in areas such as organization design, manpower planning, job evaluation and banding, HR systems and processes, performance management, compensation & benefits etc. Prior to joining Arcolab, Kalpesh worked as cluster head and principal consultant in the HR consulting vertical at Mercer India. At Mercer India, Kalpesh led the life sciences & healthcare practice and has partnered with more than 30 companies in the medical devices and equipment sector.
Dr. Sathya is a Doctorate in Philosophy and has experience of more than three decades in human relations and employee relations/ engagement activities. He has served in International Airports Authority of India, Calcutta Airport and various units of HMT and BEML. He was in the Board of Directors in the Defence Public sector BEML as Director, HR. Dr Sathyanarayan is also the Managing Trustee of Strides Foundation which is the CSR arm of Strides. He is a life member of various professional bodies viz., NHRD, ISTD, KAPSW and was the Chairman of NIPM Karnataka chapter for the years 2008 –’10.
Vinod brings 14+ years of experience with him. He started his career in researching & assessing statutory compliances of clients across various industries. He joined Strides in 2011 & has handled dispute resolutions, arbitrations & IP infringement matters in various jurisdictions. He has vast experience in handling M&As, Crisis Management, Commercial Contracts in the pharmaceutical & healthcare space and has been instrumental in various M&A and cross-border transactions with footprints in 12+ countries including USA, Europe, Australia, Singapore, South Africa & Canada.
Sukumar has over 28+ years’ experience in managing facilities and administration and has been with Strides group for over 10 + plus years now handling Global administration. Sukumar has worked in various industries like Hotel, Travel, IT, ITES, and Pharmaceutical and has been associated with companies like Quality Inns, Hical Magnetics, First ring India Pvt. Ltd. (now first source India), Porgeon ltd (Infosys BPO), Quest Global and Velankani tech park. Sukumar is a B.Com graduate and Diploma in Hotel & Travel and Tourism Management. He is also a member of ISHRAE, FM zone, CE worldwide and INFRA.
Ankit is a seasoned professional and has led different domains of Pharmaceutical Quality Systems. He has in-depth knowledge of the Quality Systems and maintained the systems ahead of curve. He has established Computerized System Validation master plans in the early stages of IT system implementation in Pharmaceutical Organizations. He has played an instrumental role in different organizations including Cipla, Ranbaxy, Sun Pharma and Glenmark to establish and maintain key quality operations including Quality Management system, Qualification of Pharmaceutical Facilities, Equipment and Systems, Audit and Compliance, Risk Management, Process governance, Cleaning and Process Validation, Batch Releases.