Our Consultants Are Our Core Strength
We have on board highly experienced and motivated professionals with deep domain knowledge of the pharmaceutical industry. A cross-disciplinary team, they have served in varying capacities at international research and regulatory bodies, including UK MHRA, US FDA, the WHO etc.
Mahboobur Rahman
President & CEO, the ITBD Group
Mahboobur Rahman earned his M aster’s in Business Administration (Marketing) from USA, Bachelor of Pharmacy and Masters of Pharmacy and a Post Graduation in Brand Management from Canada.
He has extensive training in pharmaceuticals including “Pharmaceutical Practice” at the University of Arizona, University Medical Center; marketing training on Ethical Pharmaceutical Products under International Medical Statistics (Health); and training on Good Manufacturing Practice in Manufacturing & QC under World Health Organization (WHO), making him a valuable resource at The ITBD Group.
He is the Vice-President of Canada Bangladesh Business Forum (CBBF) and Regional Head of Asia of Regulatory Affairs Associate (RAA) a USA based regulatory consulting firm and CEO of South & East Asia of NicoBloc, Ireland, besides a clutch of other pharma organizations. Rahman is the Founder President and CEO Global Medical Tourism and the main driving force behind the ITBD Group. He is a member of a slew of internally-renowned pharmaceutical organizations.
R S Swaminathan
Managing Director, SPCPL and P harmaceutical, Biopharmaceutical and API Designing and Engineering, Validation Partner of the ITBD Group.
Armed with nearly 30 years of experience in design, engineering, execution, and commissioning of basic chemical and pharmaceutical projects, he has vast experience of working with both consultants and clients.
With over three decades of industry-relevant experience with several blue-chip pharma companies in setting up ‘state of art’ Oral Solid Dosage form manufacturing facility in India. From 1985 to 1995, he was in-charge of M/s Lupin Laboratories Ltd.’s projects at Aurangabad and Mandideep in Bhopal, India, including US FDA approved Sterile and Non-Sterile Cephalosporine facilities and UK MHRA approved Aseptic Dry Powder vial filling facility at Mandideep.
As a thought leader at various international conferences on pharmaceutical technology, He has several published technical papers to his credit.
Stephen Goldner, J.D., R.A.C
Steve is the founder and President of Regulatory Affairs Associates [RAA] – a worldwide leader in getting medical devices and drugs approved by FDA and in other countries.
A chemist and lawyer, Steve has more than 35 years experience as a regulatory professional. He was Vice President for Ferndale Labs in Michigan. Steve has developed a strong track record of success and close working ties with the FDA that has worked to greatly favor our projects and clients. These interactions include work on NDA/ANDA, 510k, PMA and IND submissions, QA/QC validation and GMP compliance.
He is noted for his professionalism, knowledge and ability to navigate successfully in the complex regulatory world of medical device and drug approval. And his business sense frequently allows clients to realize hidden opportunities in this highly regulated work environment.
Susan D Lewis, Ph.D., J.D.
Susan has 20 years of pharmaceutical industry experience in regulatory affairs, product development and intellectual property. Susan was Director of Regulatory Affairs for Caraco Pharmaceutical in Michigan. Susan is a former FDA reviewer and inspector who worked at the FDA Center for Biologics Evaluation for five years before beginning her career in industry.
spent three years with Division of Vaccines and Related Product Applications as a scientific officer and reviewer and two years with the Division of Establishment licensing as an inspector.
She then held quickly escalating positions of responsibility within the regulatory affairs departments of Schering-Plough Research Institute, Knoll Pharmaceutical [now Abbott Labs], consultancies with numerous start-up companies, virtual companies and clinical research organizations.
Eugene H. Axelrod, M.B.A., Ph.D., M.D.
Dr. Eugene Axelrod coordinate s medical review and provides expert scientific review for RAA. A practicing anesthesiologist, Axelrod’s background includes innovation and development of processes for commercial manufacture of pharmaceuticals.
Dr. Eugene Axelrod coordinate s medical review and provides expert scientific review for RAA. A practicing anesthesiologist, Axelrod’s background includes innovation and development of processes for commercial manufacture of pharmaceuticals.
Dr. Axelrod’s hospital practice includes service as senior staff anesthesiologist Henry Ford Hospital, Detroit Michigan, and Associate Professor of Anesthesia and associate clinical director at University of Iowa, anesthesiologist and Chairman of Research at Sinai Hospital in Detroit as well as clinical instructor of anesthesiology at University of Michigan Medical School.
Soheil Michal El-Khal, M.S.
El-Khal’s experience in the pharmaceutical field c ombines planning, leadership, technical and regulatory knowledge to meet global objectives while ensuring compliance with FDA and health authorities around the world. She has a proven track record as an international regulatory advisor for more than 25 years.
Soheil’s remarkable accomplishments include serving as Worldwide Regulatory Strategist/International Consultant for Pfizer Drug Company. She filed 40 new therapeutic products into 12 countries [Latin America and the Caribbean] to give Pfizer a stronger presence in South America and teamed with worldwide strategists to prepare documentation for International Registration Dossier [IRD] and customized dossier [CD] for Asia, Central and Eastern Europe, Latin America, Middle East, and Africa.
Norman Howe, Ph.D.
Dr. Howe has over 30 year s experience in validation and compliance services. He is currently focusing his efforts on validation protocols and GMP compliance for various industries and product lines such as: pharmaceutical, medical device, dietary supplement etc.
He is also very engaged in developing training classes for diverse FDA-regulated industry audiences. Norman currently serves as Senior Partner of the Validation and Compliance Institute [VCI].
Jerome P. Lang, M.D.
Dr. Lang provides medical and scientific research and analysis, serving as a scientific and medical advisor. A practicing physician in Vermont, he is a highly sought-after medical writer with advance technical knowledge and experience in nucleic acids, providing reviews of clinical and analytical procedures.
Dr. Lang served on the faculty of Washington State University where he was deeply involved with health care legislation at the state level. He also participated in research projects with the WSU School of Pharmacy while serving as hospital Chief of Staff.
Aniruddha J Parmar,
Director & SBU Head – Formulation Project
Aniruddha has over 10 years of extensive experience in design and detailed engineering of facilities for Pharmaceutical Dosage Forms. He is in charge of day-to-day supervision of all engineering activities and client collaboration.
Bill Reisdorph, M.S.
Reisdorph has 30 years experience in the pharmaceutical industry. Prior to working at RAA, Bill worked for Pfizer Drug a s clinical region site manager and Warner Lambert in a number of positions of increasing responsibility including Regulatory Scientist in Worldwide Regulatory Affairs and Regulatory Compliance Auditor.
Bill has monitored clinical trials for many years and is a certified quality auditor. Bill has participated in or managed more than 25 special projects during his successful career.
Fred Reno, Ph.D.
Dr. Reno provides scientific exp ertise in toxicology, biocompatibility, drug and device development, product safety evaluation and animal testing. His 35 years experience as one of the foremost toxicologists in the world includes: organizing and directing product safety evaluations; managing contract laboratory testing; evaluating toxicology testing of devices and drugs; due diligence scientific evaluation of medical products; and writing preclinical reports for US FDA dossiers [IND, NDA, IDE, PMA].
Fred has over 20 publications in peer reviewed journals to his name. He is a member of the Society of Regulatory Toxicology, American College of Toxicology, the Society of Toxicology and the European Society of Toxicology and has advised companies and government agencies on nearly every continent.
Clifford Siporin, Ph.D.
Dr. Siporin is one of the foremost microbiologists, clinical program managers and expert witnesses in the United States. Cliff is one of those few pharmaceutical executives who knows the science, how to manage it and manage people, plus he can develop a product and express the science concepts clearly to both judge and jury.
Dr. Siporin provides advice, strategic and operational support for a wide range of applications.
Cliff has served in various senior level positions at Warner Lambert Company/Parke Davis. This included responsibility for consolidating all phases of drug development for anti-infective drugs in the USA and worldwide.
Joe Piede
President & Manager of CCE Software Inc., USA (www.ccesoft.com), a global software services provider, Piede is a leading business process consultant and trainer. He has over 34 years of experience in management, teaching and international business.
Ashis Dutta
Founder Director & CEO of CCE Software
Ashis has 25 years of experience in production planning, operations management & information systems design.
