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We are the expert FDA consultants you need to get so much done for your project quickly, simply and cost effectively. Certainly we know how to move your product through the FDA drug approval process and the medical device notification procedure. Of course we understand the difficult issues of FDA preclinical tests and GCP clinical trials.
But this select group of people gives you more than just the right answers. They give you the assurance that your project is on the right track. Our people have so many years invested in medical device and drug development that we know when something is going right and when it just doesn’t make sense.
We know what every FDA preclinical test should be, how to run that test, where and when. We know how the medical device design process fits into materials selection, SOP control, vendor selection, and so much more. We know how to fit the FDA drug approval process to your particular project parameters.
Here is a biography of all the people you will ever need as FDA consultants. They are good people you should get to know. Easy to work with, professionals all and they have worked as a team for many years to solve problems for many companies.
Just call 248 747 8008 to start getting the focused help you need from these expert FDA consultants.
Steve is the founder and President of Regulatory Affairs Associates [RAA] – a world wide 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 before founding RAA. 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.
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Julian Itzcovitz
Ph.D., Maîtrise de Physique
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Dr. Itzcovitz is one of our key consultants in the field of medical devices, medical IT and biotechnology. He has more than 25 years of experience with the high tech medical industry and held key management positions with leading edge companies in the fields of R&D, Clinical Research and Business Development.
During his career Dr. Itzcovitz managed with success several important development projects that finalized into innovative “safe and effective” products that generated high market share and excellent profitability.
His consulting activities are focused toward the following areas:
- Assistance in all the steps of product development, from concept to market,
- Design and management of mono-centric and multi-centric clinical evaluations,
- Advise and assistance for CE and FDA compliance and regulatory strategies,
- Auditing and assistance for the elaboration of product development roadmap and business plans,
- Technology and clinical due diligence.
Dr. Itzcovitz has a high degree of expertise in the following technology and clinical sectors:
Multi-modality medical imaging: ultrasound, IVUS, MRI/MRS/fMRI, multi-slice and volume computed tomography, hybrid PET/CT and SPECT/CT, optical tomography, optical coherence tomography, confocal microscopy and magneto-encephalography imaging,
Image guided minimally invasive procedures for cardio-vascular and oncology: MRT guided laser interstitial therapy (LITT), ultrasound and MRT guided high intensity focused ultrasound (HIFU) and high intensity contact ultrasound (HICU), ultrasound guided cryoablation and photo-dynamic therapies (PDT)
Minimally invasive procedure for aesthetics and dermatology applications by using innovative technologies such as: high intensity ultrasound (HIFU), high intensity contact ultrasound (HICU), laser, IPL and cryotherapy.
Image processing and medical information technology (IT): image fusion and registration, 3D and 4D visualization and manipulation, virtual colonoscopy, breast, colon and lung CAD, PACS, HIS, RIS and patient electronic records.
He is pragmatic, multi-culture, focus driven and has a proven record of effectively integrating science and business, particularly for the new emerging technologies and clinical applications.
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.
Michael is RAA Director of Business Development. He is involved with :
Project analysis and implementation.
Vendor selection and management.
Project planning and project launches.
He also maintains data integrity for more than 3000 records and develops data maintenance policies. Michael manages the day to day client operations that make the organization one of the most cost effective consulting operations in the health care field.
Prior to joining RAA, Michael worked as a paralegal for LegalTech, a web-based legal provider, the law office of McCall and Trainor and the Ann Arbor City Attorney Office.
Michael has a B.S. in paralegal studies from Eastern Michigan University where he graduated magna cum laude and was captain of the Mock Trial team. His M.S. is from Northeastern University in Regulatory Affairs.
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Eugene H. Axelrod
M.B.A., Ph.D., M.D.
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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.
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Pinya Cohen
Ph.D.
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Dr. Cohen has over 40 years of experience with biologics, drugs and medical devices through management positions in government and industry. He has overseen development, strategy and approval of viral and bacterial vaccines, plasma derivatives and other biologics including currently used :
Rabies.
Inactivated Polio.
Hermophilus Conjugate.
Accellular Pertussis.
Hepatitus B.
Rabies and Rho[D] Immune Globulins.
Anithemophilic Factor and other plasma derivatives.
Dr. Cohen served 12 years in research and regulatory affairs at the National Institutes of Heath and FDA as Chief of the Blood Derivatives Section and for 16 years as Vice President, Regulatory affairs and Quality Assurance with Merieux Institute and Connaught Laboratories [now Aventis and Sanofi Pasteur]. He also served 12 years at Nabi Biopharmaceuticals in regulatory and quality development positions for Hepatitis B, StaphVax and NicVax Vaccines.
Pinya was an NIH pre-Doctoral Fellow and received his Ph.D. in Microbiology from Purdue University. He has published numerous papers in peer-reviewed literature and served on National Academy of Sciences liaison groups and forums on blood safety and vaccine evaluation.
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Soheil Michal El-Khal
M.S.
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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;
- 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.
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Norman Howe
Ph.D.
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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.
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.
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.
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Jerome P. Lang
M.D.
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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.
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Bill Reisdorph
M.S.
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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.
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Fred Reno
Ph.D.
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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.
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.
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Clifford Siporin
Ph.D.
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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.
Deborah Theres provides regulatory research and opinions instrumental to creating INDs, NDAs, 510ks, PMAs and ANDA submissions. She has extensive experience reviewing clinical, manufacturing, and analytical data for presentation to FDA. She has over 20 years experience in the industry and has been with RAA since 2004.
She was Regulatory Affairs manager at Ferndale Labs prior to joining RAA and also served as Quality Assurance Auditor and Senior Regulatory Affairs Associate at Schwartz Pharma Manufacturing.
Debbie has extensive experience in :
CE Mark requirements for medical devices.
CMC and all other GMP requirements.
OSHA and DOT shipping and labeling.
Validation protocols and procedures.
Ms. Theres has a B.S. in Life Science from the University of Wisconsin and B.S. in chemistry from Dominican College, Wisconsin. She is a long-standing member of Regulatory Affairs Professional Society and the American Society for Quality.
Mr. Yingling has over 40 years experience with regulatory and legal issues for medical devices, drugs, food and cosmetics. He is a Partner at K&L Gates law firm in Washington DC and is available to RAA clients through a consulting agreement. While his work primarily involves the Food and Drug Administration, he also represents clients before the :
US Department of Agriculture’s Food Safety and Inspection Service.
EPA.
CPSC.
FTC.
Multiple state regulatory agencies
His practice has concentrated on :
Product labeling.
Importation.
Regulatory implications of marketing strategy.
Recalls and product seizure.
Ingredients.
Clinical trials.
Criminal matters related to product safety.
Mr. Yingling was President of the Food and Drug Law Institute for 9 years before entering private practice. Prior to assuming leadership of FDLI, he served in the FDA Office of General Counsel, first as trial attorney and later as Associate Chief Counsel and then as Deputy Chief Counsel for FDA Administration. Gary was also FDA Director of the Over-The-Counter Drug Review for several years, for which he received FDA’s highest award- the FDA Award of Merit. He was also awarded the FDLI distinguished Service and Leadership Award which honors outstanding food and drug law practitioners.
Gary worked as a community pharmacist prior to attending law school and is a registered pharmacist in Maryland and the District of Columbia. He serves as an adjunct Professor to the U of Florida School of Pharmacy.
Mr. Yingling received his B.S. from University of North Carolina, M.S. from Purdue University and J.D. from Emory University. His articles on regulations and law are frequently cited and he is the co-author of the Guide to Good Clinical Practice and editor of Quality Assurance: Good Practice, Regulation and Law.
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Diane Whitworth
M.L.S.
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Diane Whitworth provides research and document production needed to assemble documents for FDA and other regulatory agencies. She was Director of the Regulatory Research Center with RAPS, the Regulatory Affairs Professional Society. She has over 20 years regulatory and document management experience.
Ms. Whitworth has established a unique documents research service that cost effectively supports all regulatory projects and many professionals in the health care industry who conduct research on global regulatory, medical and health care issues. Her monthly columns have been widely read for many years. She has also written and edited training modules and designed and developed a number of web-based databases.
Diane previously worked for the Gillette Company, R.O.W. Sciences and Labat-Anderson and her internship was with the Library of congress. She holds a Master of Library Science from U. of Maryland and a B.A. from Vassar College.
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Frederick E. Varricchio
Ph.D., M.D.
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Dr. Varricchio is a Consulting Associate to RAA. Fred previously served as FDA drug project reviewer in the Center for Biologics Evaluation for more than 14 years. He is invaluable for guidance on developing drug programs and for presentations to FDA personnel and Expert Advisory committees.
Fred has also served as adjunct Professor with the Uniformed University of Health Science and at Howard University School of Medicine. He has over 20 publications in the field of drug adverse events and medication errors. He received his MD from Universidad Autonoma de Ciudad Juarez and his Ph.D. in biochemistry from U of Maryland. He earned his M.S. in biochemistry from U. of North Dakota and his B.S. in chemistry from U. of Maine.
Dr. Varricchio is a member of the American Association of Pathologists, American Association of Biological Chemists, American Medical Association, American chemical Society, American Association for Cancer Research, American Association of Microbiology, Association for Pancreas Research, Gesellschaft fur Biologische Chemie and Sigma Xi.
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Malgorzata Sienkowski
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Malgorzata has worked with RAA for 4 years as international documents administrator and quality control scientist. She obtained her B.S. in materials management/engineering from Warsaw Technological University.
She coordinated supply chain management activities for several freight forwarding companies in Poland prior to emigrating to the U.S. Her services are invaluable to client companies who must ship goods with accurate records over international borders.
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E Mitchell Seymour
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Dr. E Mitchell Seymour obtained his BS in Biology from the University of Notre Dame and PhD in Biochemical and Molecular Nutrition from Michigan State University.
As a scientist, he has conducted both basic and clinical research in biotech/industrial and academic settings. He has over 20 years of bench experience spanning the diverse fields of biochemistry, microbiology/immunology, nutrition, cancer biology, physiology and pharmacology. In addition, he has participated in clinical research on drugs, dietary interventions, and devices in the fields of cardiac surgery, family medicine and cardiology.
He is currently a Clinical and Translational Scholar at the University of Michigan Institute for Clinical and Health Research (MICHR) and a Regulatory Fellow in MICHR’s Michigan IND/IDE Assistance Program. He has a Dual Certificate in Pharma and Devices from the Regulatory Affairs Professional Society and is a member of the Editorial Board of the Drug Information Journal. Dr. Seymour has also provided cGMP consultancy to food companies, bulk product suppliers, food product manufacturers and dietary supplement companies. These clients range in annual revenue from to $1-250 million. Dr. Seymour also operates SciMedLit, LLC, a biomedical communications business that focuses on academic and regulatory writing.
Dr. Seymour is an active member of several professional societies including the Regulatory Affairs Professional Society, the American Society of Pharmacology and Experimental Therapeutics, the Society of Clinical Research Associates, the American Medical Writers Association and the Council of Science Editors.
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Robert Hindinger
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Robert Hindinger, MSEE, PE, PMP is an electrical engineer and inventor. He comes to Regulatory Affairs Associates with a background in clinical protocol. Robert started his career as a U.S. Navy Nuclear Officer and Tactics Instructor. He earned two navy Achievement medals for his work on US Naval Submarines.
He spent four years at Ford Motor Company as an IT Application Manager.
Robert was a founder of Jade Biomed, Inc in 2004. He invented a handheld, needle-free electronic acupuncture-based pain management system and managed the clinical protocol. He was responsible for compliance with FDA reviewers. He has vast experience in establishing viability of Class II medical devices.
At Hygieia, Inc. Robert developed a blood glucose monitoring and insulin optimizing system. He was responsible for the company’s initial regulatory compliant quality system. He has experience with start-up companies and knows what it takes to get FDA approval.
He is attending Oakland Community College for a software engineering certificate; he attended the University of Chicago International MBA program, Rensselaer Polytechnic Institute for an MSEE degree. At the Naval Academy he earned his BSEE.
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