About Us

Management Team

Mahboobur Rahman B. Pharm, M. Pharm, MBA (USA), PGDBM (Canada), President & CEO

Mr. Mahboobur Rahman earned his Masters 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).

He had experience to work in Eskayef Bangladesh Ltd, Taro Pharmaceuticals & Patheon Pharmaceuticals & Sobeys Pharmacy Group.

Mahboobur Rahman is the Vice-President of Canada Bangladesh Business Forum (CBBF)  and associated with USA, Canada and Europe based consultancy firm to provide consultancy for foreign Pharmaceutical Company to build US & UK GMP standard plant and business strategy to enter pharmaceutical product into USA, Canada & European market.

Mr. Rahman is Regional Head of Asia of Regulatory Affairs Associate (RAA) an USA based regulatory consulting firm and CEO of South & East Asia of NicoBloc a Global brand of Ireland.

Mr. Rahman is member of different pharmaceutical organizations.

Stacey L. Belding B.A. (Hon.), LL.B, Attorney at Law - bio coming soon

Dr. Sumona Maherun Nessa- bio coming soon

Our commercial partners

Regulatory Affairs Associates [RAA] www.regaffairs.net

NicoBloc Plc  www.nicobloc.com

ICE Pharma Group   www.icepharmagroup.com 

Generic Licencing Limited  www.genericlicensing.com

apibuyer.com www.apibuyer.com

Services Pharmaceutiques MD Inc www.spmd.ca

Sol-Labo www.sol-labo.com

Our comprehensive business partners and networks include pharmacists, physicians, lawyers, accountants, economists, IT providers, banks, private/ public government sector bodies, regional development & regulatory agencies, highly technological experts and more.

 

 

Our partner consultants

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. He also served as Vice President, Regulatory Affairs at ICN Pharmaceuticals, now Valeant Pharmaceuticals in Costa Mesa, California.

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.

He has generated more than half a billion dollars in revenue for various employers and clients from many product approvals during his career.

Steve has played very active roles in the Regulatory Affairs Professional Society, BIO, Michigan Life Sciences Corridor and various grant review committees that fund the medical science development community.

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 5 years before beginning her career in industry. She spent 3 years with Division of Vaccines and Related Product Applications as a scientific officer and reviewer and 2 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.

Susan earned her B.S. in Biological Sciences from Wayne State University in Detroit Michigan, her Ph.D. in Immunology and Microbiology from Meharry Medical College in Nashville Tennessee and her J.D. with a focus on intellectual property from University of Detroit Mercy School of Law.

Eugene H. Axelrod, M.B.A., Ph.D., M.D.

Dr. Eugene Axelrod coordinates medical review and provides expert scientific review for RAA. A practicising 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.

Prior to becoming an anesthesiologist, Dr. Axelrod was a practicing emergency physician at Providence Hospital in Southfield Michigan. He is Board Certified in Anesthesiology and Emergency Medicine.

Before entering medicine, Gene was a senior research fellow at Merck where he developed innovative process for commercial manufacture of pharmaceuticals including thiamin, niacin, methyldopa, cephalosporins and anthelminthics.

He was a postdoctoral research associate at Stanford University where he prepared and studied chemical cyclization of olyolefinic sterol precursors and developed a new method for stereospecific coupling of allylic systems.

Dr. Axelrod received his B.S. Science and M.B.A. degrees from University of Michigan, his M.A. in number theory from Harvard University, Ph.D. in chemistry from Stanford University and M.D. from the University of Connecticut. He speaks French, German, Spanish and Russian.

Soheil Michal El-Khal, M.S.

Ms. El-Khal’s experience in the pharmaceutical field combines 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.

She developed global strategy to optimize submission of New Chemical Entities and line extensions to national Pfizer offices.

Ms.El-Khal served as International Regulatory Manager for the Perrigo Company where she led the global regulatory team for launching generic products in 40 countries. She has also managed international medical aid projects and missions in many parts of the world.

Her work experience includes international clinical trial management for pediatric critical care drugs and bioequivalence testing.

Her M.S. degree in Pharmaceutical Sciences and Microbiology is from SUNY Stonybook and her BS in Food Technology is from Cairo University, Egypt. She is fluent in English, Arabic, French and well versed in 9 additional languages.

Norman Howe, Ph.D.

Dr. Howe has over 30 years 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, and excipients.

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].He had a long and successful career at BASF Corporation in successively more responsible positions culminating in plant manager responsibilities. He also upgraded BASF’s GMP compliance, validated API processes within the plant, and developed a new method to purify vitamin E.

Dr. Howe received his Ph.D. in organic chemistry from UCLA and his B.S. in chemistry from U of C, Berkeley.

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.

He has developed a teaching curriculum about significant public health care for pharmacists and medical professionals in many parts of the world.

 

 

Bill Reisdorph, M.S.

Mr. Reisdorph has 30 years experience in the pharmaceutical industry and has served with distinction as Project Manager on fast paced, multi-disciplinary product development activities. Prior to working at RAA, Bill worked for Pfizer Drug as 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.

He holds an M.S. in medicinal chemistry and B.S. in chemistry, both from University of Florida. Mr. Reisdorph has authored or co-authored over 20 scientific posters, presentations and peer-reviewed papers.

Fred Reno, Ph.D.

Dr. Reno provides scientific expertise 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 received his Ph.D. in toxicology from Utah State University, an M.S. in zoology from University of Nevada and B.S. in biology from U of C, San Francisco. Fred made the transition from research scientist to Vice President of Toxicology research with over 20 publications in peer reviewed journals. He is a member of the Society of Regulatory Toxicology, American College of Toxicology, the Society of Toxicology and the European Society of Toxicology. Fred has advised companies and government agencies on nearly every continent and is always traveling to new and exciting project sites.

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 really 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.

He showed this when he designed, established and implemented a unique and highly successful program to develop, register and market pharmaceutical products worldwide, including extending brand penetration and market share for multiple products in a wide range of therapeutic areas. He has direct experience in drug substance and drug product issues in multiple fields :
Manufacturing and control.
Pre-clinical and clinical studies.
Regulatory oversight for all pharmaceutical issues.

Dr. Siporin provides advice, strategic and operational support for a wide range of applications. He specifically works to enhance the efficiency of :
Drug development [for new and generic drugs].
Scientific affairs.
Drug testing.
Manufacturing compliance auditing.
Microbiology assays.
Quality testing.
Product licensing.

All of this is done to build quality and efficiency into developing and marketing healthcare products in order to increase market share and promote competitive advantage.

Cliff served as Vice President of Drug Development at G.D. Searle and Co. where he was directly responsible for all development phases for in-licensed compounds, line extensions and new dosage forms. He also 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 world wide. Cliff also served with distinction in several highly responsible positions at Pfizer Drug.

Dr. Siporin received his Ph.D. and M.S. in microbiology from University of Dayton and his B.S. in biology from SUNY, New Paltz. His professional affiliations include the American Society for Microbiology, Licensing Executives Society and the Drug Information Association. He is a fellow of the American Academy of Microbiology.

Asa Cox

Asa Cox has been active in the generic pharmaceutical sector for nearly 15 years. His experience and expertise covers the manufacture, registration and sale of both active ingredients and finished dose form. Asa is co-founder of ICE Pharma Group; a UK based sourcing and technical services business that introduces Asian pharma companies to European markets. IPG also distributes its own Rx and Medical Device products in the UK.

Having developed a global network of manufactures and buyers, Asa set up www.genericlicensing.com in 2008; the first online platform for international generic pharma business development. Genericlicensing is now the recognised industry leader; having created a Global Product Directory of registration dossiers and now advises companies worldwide on commercial topics such as; market entry, partner & product selection, portfolio development and IP management.

Asa is a retained adviser to a number of innovative European and US companies; helping them develop strategic partnerships and raise their market profile. Asa has an unrivaled online presence in the generic sector and often provides advice on personal networking as a means of business development. 

Genericlicensing is now focused on creating the same level of market intelligence in Biosimilar & Over-the-Counter sectors; both significant sources of growth for the generic sector.

Having worked on projects will nearly all global generic leaders; Asa has presented and written reports on various topics; a favorite is 'The Future of the Generic Industry', on which Asa writes a regular blog: Generic Pharma 2.0

Asa graduated from Aston Business School in Birmingham, UK with a BSc in Business Management and Entrepreneurship.

Mr. Melvin Dionne, B. Sc. (Pharm)

The principal of Sol-Labo and Services Pharmaceutiques MD Inc, Mr. Dionne has been in this field since 1976 including about 8 years in pharmaceutical firms as responsible for production, one year in R&D, 16 years as VP Scientific Affairs (QA, QC and Regulatory Affairs) than since 1999, he is consultant for pharmaceutical industries and Natural Health Product (NHP) manufacturer in QC, QA and Regulatory affairs and also he handles his own manufacturing laboratory (Sol-Labo) and does contract manufacturing as well as import of NHPs. His Regulatory Affairs team is specialized in the Canadian regulation concerning drugs, cosmetics and natural health products. Canada has adopted a regulation on Natural Health Product that established very high standards for NHP that are close to those for drugs. Mr Dionne’s group is highly respected by Health Canada’s reviewers and has helped many NHP manufacturers to obtains market authorisation for their NHPs in the new Canadian NHP Regulation environment. Services Pharmaceutiques MD Inc in a leader in NHP Product Licence application in Canada.

 

Call or email us at 1-647-707-36291-647-707-3629 or info@itbdg.com