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Arun | | | Banu | | | Carl | | | Jay |
The Pharmax Consulting Services was founded by Mr. Arun D. Kulkarni with many of his distinguished colleagues, who have several years of progressive & diversified experience in the Pharmaceutical Manufacturing, QA/QC, Regulatory Affairs, Process Validation, Compliance Auditing, Pre Approval Inspections, and FDA liaison. A short biography and expertise of the Pharmax Principals is described below:
Mr. Arun D. Kulkarni, the President
of Pharmax, Inc., has over 22 years of progressive and diversified management
experience in the Pharmaceutical and Allied Industries ranging from start-up companies
to multi-national organizations. Arun’s areas of expertise include deployment
of Quality & Compliance in the organizations. Being an expert in diagnosing technical
& administrative problems he has recommended & implemented several innovative
solutions.
Arun has experience in both OTC and prescription drug products and has single handily turned around companies in difficult situations. He offers dynamic leadership in moving organizations into a profitable company. He has experience in modernizing the manufacturing plants, making profitable deals and is visionary in identifying and achieving company’s goals and objectives. He is highly motivated, dedicated and results oriented in management style.
Arun has held several responsible positions at generic and multinational firms. In the last two positions as a V.P. of Scientific & Regulatory Affairs, he led a large organization of Quality, Regulatory and Validation professionals and was instrumental in establishing Quality Council of a world-wide company He has successfully help build Manufacturing Facilities for various dosage forms including Aerosols and managed them for GMP compliance.
His educational background includes a BS in Pharmacy, M. Pharm. in Pharmaceutics, MS in Industrial Pharmacy and MBA He has progressive experience in the areas of Manufacturing, Quality Control, Quality Assurance, Regulatory Affairs. Plant Design and R&D.
Dr.
Banu Ramachandran, is also one of the founding member
of Pharmax and is the Director of Regulatory Affairs. Banu has over 15 years
of research experience in Microbiology, Molecular biology and Biochemistry.
As a consultant to Pharmaceutical & Allied Industries,she has acquired a wide
and through knowledge on several aspects of cGMPs, and FDA regulations. She
has designed and implemented controls to ensure that the product is manufactured
under GMP compliance. She has also designed a new product launch model and is
experienced in the direction and management of quality control/quality assurance
operations. She also has experience in compiling ANDA / NDA submissions, SOPs
for all areas of QC & QA, protocols and reports. She has held Senior Scientist
positions at Children’s Hospital of Philadelphia and conducted post doctoral
research at University of Medicine & Dentistry New Jersey. She has co-authored
many scientific articles and presented papers in national and international
conferences
Banu has an M.S. in Biochemistry and Ph.D. in Microbiology and Cell Biology. She has also successfully completed the Regulatory Affairs Certification (RAC) Board examination.
Dr.
Carl R. Rehm is a Senior consultant and has over 34 years
of broad experience in the pharmaceutical industry with Rhone-Pulenc Rorer,
Revlon Health Care R&D, Bristol Laboratories and Ciba-Geigy Corp. in the areas
of Research & Development of ethical drug products, Quality Contro/Quality Assurance,
Technical support to manufacturing, including Process improvement and Process
validation. Dr. Rehm has been a consultant to the Health Care Industry for the
past seven years in the areas of R&D, manufacturing, QA/QC, Reg. Affairs and
has provided technical support to more than twenty pharmaceutical and device
companies.
Dr. Rehm is experienced in the development and implementation of GMP procedures, designing protocols for human Bioavailability studies and has considerable background in the preparation of technical documentation for IND, NDA and ANDA submission to the FDA. He has directed research & development activities embracing a wide range of new drug products, including, antibiotics, peptides anti-neoplastic agents, steroids and cardiovascular drugs, protein derivatives including hyper-immune gamma globulins & purified Factor Eight.
Dr. Rehm hold an M.S. and Ph.D. in Pharmaceutical Chemistry and B.S. in Pharmacy. He has published more than 20 articles in the areas of pharmaceutical and analytical research and quality control. He is Associate Director at Pharmax and also on the Board of Director of Pharmax.
Dr.
Jay Tatake is an accomplished organic chemist with several
years of experience in the field of Analytical Sciences, R&D, Product Development,
Quality Control. He has extensive experience in developing analytical methods
both in academic and industrial environments. He has developed various chromatographic
techniques for analysis and conducted stability studies of small and large organic
compounds. He also has expertise in analyses of plant and animal tissue extracts
and metabolites.
Jay has a Ph.D in Organic Chemistry and Masters in Chemical Technology. He is a member of American Chemical Society (ACS). He has published several papers in leading journals He has held positions in various levels in reputable academic institutions and pharmaceutical/chemical industry.
In addition to the above mentioned people, Pharmax has many experts in the other fields such as Pharmaco kinetics, Formulation, Validation (Process and Analytical), GMP Compliance etc.