Dr. Gurudatta G.G. has a manifold 29 years of experience spanning areas of pharmaceutical and CRO industry and has cleared 35 International regulatory audits for his clients.
He has a Bachelors of Science degree in Chemistry from Karnatak University, DIAC from Ruia College Mumbai, MBA in Quality Management from University of Grantchester USA and PhD in Quality Management from University of Grant Chester USA.
He is concentrating on GxP consulting business since February 2006 and has worked with many Indian Pharmaceutical companies and International Pharma companies. He has started working with a Korean based Pharma Company for their EU approval process. Apart from this, he engages in performing third party audits and Gap analysis for many clients in Europe & US.
Dr. Gurudatta apparently trained under WHO Geneva in Quality Management Systems, holds a Bachelor’s degree in Chemistry, Diploma in Industrial and Analytical Chemistry from Ruia College Mumbai, Diploma in Pharmaceutical Quality Control and Quality Assurance Management with Post Graduation in Marketing Management and Diploma in Management from IGNOU, Delhi.
A perfect think tank, he has forayed into collaboration with a UK giant to institute a intrinsic, comprehensive platform for solutions including services on Data Integrity for Indian Pharma Companies and keen to establish competence of international standards on GMP guidelines.
Mr. Hegde is a pharmacist with basic degree in pharmacy from Bangalore University. He has done M.S in Pharmaceutical Technology from Vinayaka Mission University Salem. He has got Master in Business Administaration from Manipal University (SMU) and completed Executive General Management Course (EGMP) from Indian Instititute of Management Bangalore (IIMB). Apart from this, he has got ISO Lead auditor certification from NIGEL BAUVER from UK.
Professionally, Mr.Hegde has handled series of responsibilities from Operation to Quality during his 19 years of tenure in top class pharma companies. He has started his professional journey as Production chemist and handled operations in the rank of General Manager, Vice president-Operations and Sr.Vice President-Technical which is comprising of Manufacturing, Engineering & projects, Technology Transfers, Quality control and Quality Assurance functions.
During his tenure, he has handled different pharma projects in Oral solids, Semi solids, Oral liquids and R&D; successfully. Handled more than 100 process developments and technology transfer projects during his tenure for International markets. He is known as one of the best administrator, trouble shooter and team player in the industry.
As Operation and Quality head, he has handled almost all major regulatory audits several times, like USFDA, EMA, MHRA, TGA, ENVISA, MCA and others audits successfully.
Dr.Gundu H. R. Rao obtained his B.Sc degree from the University of Mysore and B.Sc (Hons) and M.Sc., degrees from the Poona University. He worked for an year with the Commonwealth Institute of Biological Control, Bangalore and five years at the Central Food Technological Research Institute, Mysore. He immigrated to the USA in 1965 and specialized in grain storage technology and obtained his Ph.D degree from the Kansas State University, Manhattan, Kansas. After working as a post-doctoral fellow at the Texas A& M University and University of Minnesota, he joined department of Pharmacology as an NIH fellow to get training in toxicology. He has been with the University of Minnesota Medical School for over 40 years. He is a naturalized US citizen and a tenured professor in the department of Laboratory Medicine & Pathology. He also has faculty appointments in Anesthesiology, Lillehei Heart Institute, and Biomedical Engineering Institute. He is an author or co-author of over 300 publications in the field of interest (thrombosis and stroke). In the past, he has consulted various medical device development companies in the Twin Cities including 3M, Medtronic Inc, St Jude Medical, Medical CV Inc, Vascular Solutions, APP Tech, Endocardial Solutions, PlaCor Inc., Medical Innovations Inc, Hypertension Diagnostics Inc. and Boston Scientific on problems related to biocompatibility, thrombosis and stroke.
Dr.Rao helps Newwill with Novel drug delivery systems(NDDS), product development in cardiology and Diabetology segment, Phytocemical based drug development and development strategy for the company.
