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Accutest Biologics

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    Atul Solankar
    Mr. Solankar has a Masters’ degree in Pharmacy with more than 21 years of experience in Clinical Research having worked with companies like and Bharat Serums & Vaccines, Ranbaxy, Siro Clinpharm and Lambda. He has been working with Accutest for more than a decade now and is responsible for Global Business Development, establishing business relationships and growing client base. Prior to his current role he was heading the Quality Assurance and Regulatory Affairs of the company and was responsible for compliance and adherence to all required international quality standards, implementation and assurance of high standards of quality, and also for the regulatory submissions and inspections. He has to his credit a rich experience of handling more than 100 regulatory inspections from various international bodies like USFDA, EMEA, ANVISA, WHO, MCC(South Africa) and many more.
    Dr. Anita Samagod
    Dr. Anita Samagod is a Ph. D. in Chemistry from Institute of Chemical Technology (UDCT). She is a skilled professional with more than 20 years of extensive experience in managing research and development projects, biotechnology product development pathway, product characterisation, bioanalytical method development and dealing with regulatory authorities to support product development for pharmaceutical and biopharmaceutical companies. As Chief Scientific Officer and head of Biologics, Dr Anita Samagod is responsible for managing the Biologics team that develops and implements various bioanalytical methods to support product development and delivering quality services for biologics and biosimilars for regulatory submissions.
    Dr. Abhijit Damre
    Abhijit Damre holds a Ph.D. in biopharmaceutics from the University of Mumbai. He has over 20 years of experience in the clinical research industry in various leading global organizations like SIRO Clinpharm, PPD, Quintiles and Parexel prior to joining Accutest. He is responsible for leading Clinical Development Services- mentoring and developing teams in clinical operations, data management, biostatistics & programming and medical writing for Phase I-IV clinical trials.
    Dr. Suhas Khandave
    Dr. Suhas Khandave is a post-graduate medical professional (Clinical Pharmacologist) with 19 years of rich experience in Academics, Pharma, and CRO industry. The primary area of expertise includes Clinical and Statistical operations. He acts as a key decision-maker, solution provider for increasing productivity and turning around difficult situations. He is an active participant in various events like regulatory meetings, presentations, conferences and workshops on a global platforms. He also has many national and international publications to his credit.
    Dr. Ashutosh Pudage
    Dr. Pudage is a Ph.D in Analytical Chemistry from Mumbai University and is the President of the Bio-analytical department at Accutest. He has 18 years of experience in the area of bioanalysis. Before joining Accutest, he has worked as a principal scientist in the pharmacokinetic department at the Glenmark Research Center and with the Torrent Research Center. He has vast regulatory experience in audits of different regulatory agencies and has several publications on bioanalysis in peer-reviewed national and international scientific journals.
    Dr. Hari Sankar
    Dr Hari Sankar obtained his Doctorate from Banaras Hindu University after his B. Pharm and M.Tech. He has over 24 years of experience in CRO and Manufacturing Industry. His experience varies from heading Lotus (a TEVA company)for about 6 years and managed over 600+ beds in India and USA and 50+ Mass specs. He was in-charge for 6 locations and managed end to end Bioequivalence studies. He has set up the patient based studies and hosted more than 65 GCP inspections.

    Dr Hari Sankar has significant GMP manufacturing experience at Dr Reddy’s Laboratories and Aizant Drug Research Solutions. At DRL he pioneered SMT concept that is adopted across the DRL now.

    Pramod Dubey
    Mr. Dubey is a certified Chartered Accountant & Company Secretary with an experience of 2 decades. He established, implemented and maintains financial planning, budgeting, forecasting and corporate governance at Accutest. He secured financing through debt and equity (private equity investors) and in establishing multiple clinical infrastructures in facilities in India and globally. Prior, he has worked with Indoco and Camlin.
    Dr. Satish Sawant
    Dr. Sawant is a Ph.D in Analytical Chemistry and co-founded Accutest in 1998 after 12 years of experience in the pharmaceutical field with Merck and Kopran. His earlier research work’ focused on the development of analytical methodologies for the assessment of bulk drugs and their marketed formulations. He has 18 national and international publications to his credit and is an active member of the Indian Pharmaceutical Association, a committee member of India’s FDA, and IDMA (Indian Drug Manufacturer’s Association). He is also a visiting faculty at Mumbai University.
    Dr. Mallikarjun Dixit
    Dr. Dixit (graduate from University of Illinois) is a scholastic personality with several patents and publications to his credit and with more than 25 years of rich experience in pharmaceuticals, biopharmaceutical, and CRO industries in the area of drug discovery and bio-analytical services. He has extensively worked on method development and validation of various assay platforms such as LC-MS, ELISA, MSD, SPR, RIA/RIPA and Cell-based assays for Immunogenicity and pharmacokinetic evaluation of non-clinical and clinical study samples under GLP and GCLP compliant practices for regulatory submission studies. As a test facility management and head of the bioanalytical laboratory, he has successfully faced multiple sponsors and regulatory audits. Dr. Dixit with his expertise is currently guiding the team biologics in the delivery of quality compliant bioanalytical and Characterization services for biologics and biosimilars for submission studies.
    Dr. Nirav Gandhi
    Dr. Gandhi is a Clinical Pharmacologist with around 14 years of experience. He has worked with major Indian pharma companies like Cipla, Torrent and Intas. He is a co-head of our BA/BE division with more than 500 professionals. He is responsible for ensuring quality, financial probity, operational performance and various regulatory approvals. He played instrumental role in initiating our clinical trial business. Dr. Gandhi is an honorary lecturer at various Clinical Research Academic Institutes and has participated in various national and international seminars and conferences as a speaker and chairperson. He is also a member of advisory board for clinical research programs at Gujarat University.
    Rajendra Talele
    Mr. Talele (M. Pharm, MBA) holds 20 years of experience in the drug development Industry. He has worked in various leadership positions in pharmaceutical and CRO companies like SIRO Clinpharm, PharmaNet Clinical Services, Quintiles Spectral, and Wockhardt prior joining to Accutest. He set up the operations in India and South East Asian region and expanded the clinical development operational capabilities in Eastern European countries. His area of expertise includes building organization, leadership, mentoring and driving teams.