Management @ Bion
We take the science forward, while keeping our focus on people.
Leadership @ Bion
Facility managed by a team of highly skilled and experienced scientific professionals who meet the applicable GCP and GLP guidelines. The team is well versed with all the regulatory compliance, different guidelines
and have faced various regulatory audits successfully.
Head QA
Vishwas Pukale
Mr. Vishwas is a veteran CR professional and has total 20 years of experience in pharmaceuticals and quality assurance in CRO industry. Earlier he worked with Themis, Macleods, Accutest Research, Raptim Research.
He is well-versed in applicable Regulatory requirements GMP, GCP, GLP, and clinical research processes. He has faced several regulatory audits and inspections by immanent regulatory agencies, including but not limited to DCGI, USFD EMA, ANVISA, UK MHRA, MCC, and WHO.
Head Clinical Services
Dr. Atul Apradh
Dr. Atul has total 20 years of experience in clinical practice and clinical research (Bioequivalence studies)
He has also worked with various Hospitals and pharma companies like Emcure Pharma, Anazeal, Bio Radius, Bio SRL & have faced the USFDA Audit in his previous assignments and having exposure of various regulatory audits like DCGI and USDA.
Head BA
Mr. Vinayak Bhosale
Mr. Vinayak is a total 12 years of experience in CRO industry and holds the post graduate degree in Organic Chemistry.
His earlier engagement was with Centura, Accutest Research, Lotus, Synergen Bio with over a decade of experience and notable portfolio of few publications. He has been part of many successful audits of DCGI, USFDA, ANVISA, EMA and WHO in his previous tenure.
Head M. W. and P.M.
Mr. Rahul Kapse
Rahul Kapse has 15 years of experience in Medical writing, Project management and Regulatory affairs for BA/BE studies and clinical trials and has handled various markets in this period. He is responsible for Protocol writing, CSR writing, regulatory applications, maintaining client relationships as per the organization's requirement. He has detailed knowledge of Regulatory requirements, Pharmacokinetic profiling, GCP and ICH guidelines. Rahul has successfully faced several regulatory audits of like DCGI, EMA and USFDA. He holds a master's degree in pharmacy.