Trans Integra Healthcare was founded on the firm conviction to Provide Timely, Accurate and Transparent Critical Business Support To UNLOCK Business Uncertainty.
Our consulting Philosophy is based on:
A medical post-graduate with 17+ years of experience in pharmaceutical/medical device industry, with experience at Regional & at Global Leadership levels in the R&D at several Global MNC’s (Novartis, Allergan, Santen Japan) & Indian BIG Pharma Companies (Dr Reddy’s, Torrent Pharma, Cadila & Piramal Healthcare), His last full time assignment was with Novartis Research & Development as Site Head, Drug Regulatory Affairs & the Sub-Regional Head (AMAC, GEM, and LACAM Regions), leading a team of more than 100 Scientists. At Novartis, he was part of Novartis Drug Regulatory Affairs Global Leadership Team. Prior to Novartis, he was with Allergan India for 4.6 years, heading the Scientific & Regulatory Affairs functions (South Asia); and Lead Pharmacovigilance for Asia. Apart from core Scientific & Regulatory Affair functions (South Asia), he was additionally responsible for Clinical, Non-Clinical and CMC aspects of Regional Product Development Initiatives. Apart from his assignments in MNC Pharmaceuticals, he has been associated with Dr. Reddy’s Laboratories (Associate Director, Corporate Medical & Regulatory, 2006-7); as Senior Scientist, Clinical & Regulatory in Torrent Pharma, leading successful audit of ANVISA Brazil in 2003. He started his professional life as a Medical Advisor in Nicholas Piramal (2000), moving on as Head of Piramal’s CRO where he was instrumental in setting up the Human PK Unit (2001). Between 2013 and 2016, while establishing Transintegra, he held several positions – as Director, Clinical Development & Regulatory (South Asia) with Santen Japan (2013-16) and on Board of Director with Microsec Group (2013-2015). Under his guidance, Transintegra has moved into core Research & Development to explore Proprietary, Affordable Point-of-Care Diagnostics. The 1st two projects are under partnership with the BIRAC/Department of Biotechnology (Gov of India). He is the Founder & Managing Trustee of Trans Integra Healthcare Research Foundation (http://www.trcfoundation.in) (a “not-for-profit” organization), established with key focus to connect researchers, patients & policy makers in healthcare. LinkledIn: Dr Shushil Choubey
Mr. Lalit has held senior management positions in manufacturing operation, production and technical training at Mylan, Pfizer, Dr Reddy’s Laboratory and many Indian Big Pharma’s over the last 30 years. With a successful record of leading several health authority audits from MHRA, USFDA, ANVISA, WHO, PICs as the plant head. And, successful commissioning of several Green Field Projects in different parts of India. Mr. Lalit completed his B Pharm from Jadavpur University. M.Pharm from I.I.T., B.H.U. His last full time assignment was with Mylan (Global Generic Co) as Head of Technical (GMP) Training, Hyderabad. Prior to Mylan, as Associate VP at Wockhardt, he held positions of Site Head for EOU-Tablet Biotech Park, Aurangabad; Site Head of Baddi Plant and Chikalanta Plant, all of which were USFDA/MHRA approved sites. At Unichem Laboratories as Site Head & General Manager responsible for Sterile Dry Powder Injection, Tablets, Capsules and Dry Syrup. He was responsible for commissioning of the Greenfield project of US-FDA, MHRA standard with INR 45 Crore for a capacity of 1.8 billion Tablet / Capsule per annum. And, leading the team in the MHRA, ANVISA and ISO 9001/14001 approvals. Between 1996 & 2003, he was with Dr. Reddy’s Laboratories as Plant Manager. And between 1991 to 1996 with Boehringer Mannheim (I) Ltd. as Sr. Manager, Production & Pfizer Ltd as Production Manager with successful commissioning of New Green Filed Plant for Solids Oral & Liquids at Boehringer.
Mr. Rao is a seasoned professional in the Pharmaceutical Industry, with more than 35 years of experience. His last full time assignment was with Sun Pharma, India as full time consultant, responsible for implementing cGMP awareness, training manufacturing staff, internal review and feedback to management on GMP. Having facilitated the cGMP in more than 20 Manufacturing Sites throughout India. Mr. Rao has specific skills in preparing highly customized training modules based on Company’s need and WHO/PICS Guidelines, CFR Part 210, ICH GDP, ICH GWP, Indian Schedule M, & USFDA 483 observations. Over the years, he has facilitated need based GMP training through International domain experts. Mr Rao’s has been associated in past with RPG Life Science, Alembic, Knoll Pharmaceuticals & Cadila Pharma.
Soumya holds a Master of Biotechnology from KIIT University. He has sound hands on experience in biochemical and immunological techniques and molecular biology and recombinant DNA technologies and microbial technologies. In the past, he has worked in various R&D projects for development and validation of hand sanitizer, Trans Dermal Pain gel and optically tuneable Nano-biosensors for environmental monitoring. Soumya has strong Organizational Analytical and Management Skills; he has experience in writing manuscripts, critique analysis, dissertation thesis within deadline and without plagiarism, with a sound experience of intext as well as End referencing in all styles such as Chicago, MLA, Harvard, and Vancouver etc.
Subhra gained research experience during his MSc. in Biochemistry at MPC Autonomous college, North Orissa University and as Research Trainee at Department of Biochemistry in National Rice Research Institute (NRRI). He also took training in Institute of Minerals & Materials Technology (IMMT). In Trans Integra, he is engaged in review of Regulatory documents, Preparing CTD, GMP, Compilation of technical summaries, Preparing checklist, Project Team Leader, Expert summary, Abstracts, Scientific presentations, preparing PSUR, preparing regulatory news & blog updates. Subhra has keen business interest, flexibility and deep understanding of clients’ needs for comprehensive, robust and successful solutions. He has several publications in Journals and has significant experience in Regulatory & Quality Assurance.
Zunaid gained research experience during his MSc in Biotechnology at Institute of Genetics Engineering, West Bengal University of Technology and gained knowledge in Bioinformatics and Biotechnology. He has interests in Scientific Communications. In Trans Integra, he is engaged in review of ADRs, compilation of technical summaries, product rationale, competition analysis, expert summary, abstracts, scientific presentations, preparing regulatory news & updates.
Swikruti has completed her MSc. Bioinformatics from (OUAT) and did her P.G Diploma in Clinical Research from Syncorp Clincare, Bengaluru. She has core interest in Data Management, SAS Programming. In Trans Integra, she is engaged in data analysis of ADR reports. Besides, dealing with several works related to Clinical research.
Sradha has completed her B. Tech & M. Tech in Biotechnology from KIIT University. Having Food Technology as an elective subject, and good understanding of food/dietary supplements. She has a hands on experience in biological and chemical laboratory techniques. She has worked as a Software Developer and has hands on experience in designing websites, use of data base servers, data processing systems. She has recently joined Trans Integra, and is contributing to on-going projects. Apart from her technical skills, Sradha has keen interest in Marketing and Business Administration.
Sudipta has completed her B. Tech & M. Tech degree in Biotechnology from KIIT University. Sudipta has experience in various techniques in assay of chemicals and biological materials and in biotechnology tools. She has undertaken specific trainings in IPRs-Patents, Copyright, Trademark, Geographical Industrial Designs and Trade Secrets and gained hands on experience in patent application procedure in India, USPTO, EPO and patents search techniques. She has specific interests in regulatory affairs and quality assurance related to medical device. Apart from her core technical skills, Sudipta has keen interest in Marketing and Business Administration.
Dr Ravi has more than 18 years of experience as a physician having completed his MD (post-graduation in internal medicine) in the year 2002 & his DM in medical oncology from All India Institute of Medical Sciences, Delhi, India in year 2007. Dr Ravi is member of the Brunei Medical Council, the Bahrain Medical Licensure (till 2013), Association of Physicians of India (Life member), and Member of Bahrain Medical Society, life member of the ICON-India, Member of European Society of Medical Oncologist, the American Society of Clinical Oncology, the International Association for the Study of Lung Cancer, the Indo-American Cancer Association & the Indian Medical Association. He also holds medical licenses from Bahrain & Brunei and has experience as a European certified medical oncologist. Dr Ravi has done extensive research work related to analysis of adult Acute Lymphocytic Leukaemia (ALL) case outcomes and RTPCR analysis of common mutation in adult ALL cases at the All India Institute of Medical Sciences, leading to several publications in haematological malignancies, malignant melanoma, and the germ cell cancers and breast cancer. At present Dr Ravi is a Consultant Medical Oncologist at the Department of Oncology, TBCC, Jerudong Park, Brunei.
Dr Alok is a Consultant in Anaesthesiology & Critical Care. He has been at Narayana Hrudalaya, Care Hospital, Batra Heart Centre managing critical care and anaesthesia. He is specifically trained in Trans-oesophageal ECHO, Continuous Cardiac Output monitoring devices and Percutaneous Tracheostomy. He has interests and expertise in Paediatric and Neonatal cardiac anaesthesia, post-operative care, apart from which Alok contributes to management role in coordinating clinical survives, monitoring and resource utilization, monitoring and audit.
Prabhakar is an accomplished Marketing & Sales professional with 25 years of experience with rich, cross functional exposure to the entire spectrum of Sales, Marketing and Business Development in Pharma Industry. He is the Founder Director of Zorticos Lifesciences Pvt Ltd, Mumbai, a start-up cosmeceutical company. Prabhakar is an M.Pharm (UDCT, now ICT) and MMM (NMIMS), CPDM (Digital Marketing). Prabhakar is a Consultant to Pharmaceutical Industry, Pharma Digital Marketer, Undertakes Training and Development Programs for sales and marketing teams and Executive Coaching to Senior Level Managers. In the past he was as Vice President–Sales & Marketing with Centaur Pharma for last 6 years, with other previous assignments includes Marketing Head in Alkem Ulticare, CFL Pharma, Cadila Pharma, Concept Pharma and Mapra Labs. He has experience of managing many megabrands and market leaders like Sinarest (Centaur) – No.1 prescribed anticold in India, Ocupol and Ocurest (Centaur) – brand leaders in their respective categories, Swich (Alkem) third brand in Cefpodoxime, Jectocos (CFL) brand leader in injectable iron formulations and Envas (Cadila Pharma) brand leader in enalapril market.
Sunando is a seasoned Quality Assurance Professional & Auditor, with significant hand on experience in managing Quality in Early Drug Discovery Research, Pre-clinical Research (Regulatory Pharmacology & Toxicology), Human Kinetics & Clinical Pathology Studies with specific interest in 21 CFR Part 58, OECD GLP, ICH GCP, cGMP, GRP, ISO 15189, ISO 9000, ISO 17025, ISO 19011 standards. He started his professional career with Torrent Research Centre of Torrent Pharmaceutical Ltd, as a Scientist in Quality Assurance Department in 2001, later moving on as Head Quality Assurance in Accutest and TCG Life Sciences Ltd. He is a member of the British Association of Research Quality Assurance, the Society of Quality Assurance (SQA)-USA, Indian Pharmaceutical Association etc. Sunando completed his Masters in Pharmaceutical Sciences (Specialization in Quality Assurance) from Rajiv Gandhi University of Health Sciences, Bangalore, India.
With over 24 years of experience in the Pharmaceutical industry, Dr. Bhaduri, has worked in the biggest Indian pharma companies such as Ranbaxy, Dr Reddy’s, Lupin, Nicholas Piramal and Cadila Pharmaceuticals in senior management position. In his last four assignments, he was the Head of Medical Affairs designated as Medical Director. A medical graduate from Medical College, Calcutta in 1986. Dr. Bhaduri completed his MD in Pharmacology from Institute of Medical Sciences, BHU in 1989. After a brief stint of Senior Residency in University College of Medical Sciences, University of Delhi he joined the Pharmaceutical industry in 1990. More recently, Dr. Bhaduri has expanded his expertise by holding key positions in a CRO and managing a multispecialty hospital. Dr. Bhaduri brings immense volume of experience in Medical Affairs, Clinical trials (Phase III and Post-Marketing), Pharmacovigilance and registration of new products with local regulator. Dr. Bhaduri credits himself with an ability to build and lead teams, a knack for understanding organizational priorities and work seamlessly with cross functional teams. In his career Dr. Bhaduri is privileged to have worked with several top notch professionals, bright colleagues and exemplary customers. Dr. Bhaduri credits himself with the ability of marrying technical knowledge with business priorities of the organization in his assignments. Apart from his responsibilities at TransIntegra, Dr. Bhaduri currently serves as a Consultant for a reputed pharmaceutical organization.
Dr. Neera’s past professional engagements includes Senior Scientific Writer at Novartis Healthcare, Senior Editor in a Scientific Publishing Company, Senior Research Assistant at MD Anderson Cancer Centre, Houston, Texas, USA. Neera completed her Ph.D. in Biochemistry/Molecular Endocrinology from the National Institute for Research in Reproductive Health (NIRRH), Mumbai, India. She has interests in Cancer Biology, Pharmacogenomics, Maternal and Child Health, Tuberculosis and Reproductive Health. She has significant contribution as author and editor in Scientific & amp; Clinical Communication, having accomplished authorship in several international journals of reputation such as Blood, Clinical Cancer Research, British Journal of Clinical Pharmacology and Journal of Biological Chemistry, etc. She is a recipient of DBT-Bio Care Women Scientist Grant to carry out a research project on salivary diagnostic biomarkers in oral cancer. She has more than 10 years of experience in various scientific writing tasks and is an accomplished scientific editor. Neera has worked extensively in clinical settings such as the NIRRH, Mumbai, India and MD Anderson Cancer Centre, Houston, USA and has exposure to most sophisticated facilities both in India and USSA.
Nisha is a medical professional with a Master’s degree in Clinical Research and a dual Master’s in Management. An experienced pharmaceutical professional with strong technical and leadership experience in the field of Pharmacovigilance and Medical Communications, she started her professional career in research at NIMHANS, Bangalore in 2007. Nisha has moved professionally with greater responsibilities and skills. She was associated with Quintiles Transnational, Bangalore as Senior Drug Safety Associate, supporting and mentoring a team of 19 people, during her tenure she won several leadership awards. Post her assignment at Quintiles, Nisha was a Team Lead, Medical Review with Accenture Pharmaceutical Services where she was both a team manager and individual contributor managing MedDRA coding, causality assessment, medical review of safety data, project management and client interfaces. Along with her team, she was involved in setting-up and implementation of safety SOP’s. As an independent consultant, Nisha is well quipped in end to end activities in Pharmacovigilance, over the years authoring numerous high quality aggregate safety reports including PSUR, PBER, PADER, EU RMP, REMS to meet regulatory deadlines. She has authored clinical protocols, study reports, and prepared and reviewed scientific publications. Later, she has been working as the Vice President- Pharmacovigilance and medical writing at Thinki taking up business development as an additional task. Having worked with established multinationals and start-up companies, Nisha has keen business interest, flexibility and deep understanding of clients’ needs for comprehensive, robust and successful solutions.
Dr. Madhumita is a physician by education having completed her MD from Ukraine in year 1993. Madhumita has rich experience in emergency medicine both in India and in USA, having worked at Safdarjang hospital, New Delhi; and later worked at various medical centres in the USA starting with the Providence Hospital, Washington DC, USA in year 1996. She later joined the Endocrinology, Geriatrics, Anaesthesiology and Radiology units of Veterans Affairs Medical Centre, Washington, DC, USA and the Dept. of Anaesthesiology, at the University of Massachusetts, USA. Madhumita’ s last position in the USA was at the Department of Neurosciences, NINDS, National Institutes of Health, Bethesda, MD, USA, where she did several projects in animal neuroscience models. Madhumita has several publications in Medical Journals and with her growing interest in Clinical Research, she has completed her Post Graduate Diploma in Clinical Research.
Dr Sahoo has interests in Pharmaceutical Analysis, Pharmaceutical Inorganic Chemistry, Pharmaceutical Engineering, and Analytical Technique in Food, Cosmetics and synthetic drugs. He has considerable experience in Scientific Writing, having accomplished authorship for 15 articles in several international journals of repute, in the field of Pharmaceutical Sciences and Chemistry. He has handled both finished products and bulk drugs of Atorvastatin, Simvastatin, Clopidogrel, Loratadine, Meloxicam, and some of the most successful drug. Dr Sahoo has completed his M. Pharmacy (Pharmaceutical Analysis & Quality Assurance), and his Ph.D. from Siksha "O"Anusandhan University, Bhubaneswar, India.
Dipika gained experience in pre-clinical research during her M.Sc. in Biotechnology and as a Junior Research Fellow in Department of Infection Biology, KIIT University. Recently she completed an Advance Course in Clinical Research and Management. She has interests in Scientific Communications. In Transintegra, she is engaged in review of technical documents, compilation of technical summaries, product rationale, competition analysis, expert summary, abstracts, scientific presentations, preparing scientific news & updates.
Dr Pandey is a practising advocate in the High Court at Hyderabad having obtained his LLB in law from Osmania University, Hyderabad. After serving a long stint in Indian army, Dr Pandey also obtained his degree in alternative medicine and certification in Business Management. He brings in nearly two decades of experience in administration at various levels. Dr Pandey has particular interests in medico-legal cases, cyber-crime and patient laws. He is passionate about various initiatives he has undertaken for welfare of Senior Citizen and Orphan Children. Dr Pandey is located in Hyderabad.
With 30 years of successful experience in various positions in sales & marketing, started his professional life in pharmaceuticals in the year 1981 with US Vitamins. From 1983 to 2003 Prasad was with Roche, rising to a regional manager in sales, with rich experience in specialties like gynaecology, orthopaedics, neurology, psychiatric, diabetology, etc. In his span of 30 plus years in Roche and USV Mr. Prasad had successfully built several key brands in India.