Regulatory Affairs Associates

We are the expert FDA consultants you need to get so much done for your project quickly, simply and effectively. We know how to move your product through the FDA drug approval process and the medical device notification procedure. We understand the difficult issues of FDA preclinical tests and GCP clinical trials.

This select group of people provides you with 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 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. This is a group of extremely experienced professionals that have worked for many years solving problems for many companies. Contact us to start the process of getting your drug or device through approval.

Stephen Goldner Esq, RAC

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 forensic toxicologist and lawyer, Steve has more than 40 years experience as a regulatory professional. Steve began his career at the Chief Medical Examiner’s Office in New York, developing the first reliable drug screening tests for many drugs, and launching the Drug Screening industry. He then developed the drug methadone, getting FDA approval and managing that start-up company. Earning his law degree and serving the medical device and pharmaceutical industry as FDA expert advisor in large and small companies.

Steve has developed a strong track record of success and close working ties with FDA, NIH, state regulatory agencies and multiple regulatory agencies outside of the USA. Those relationships have 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.

MICHAEL TOMASOVICH M.S. RAC

Michael is RAA’s Director of Business Development, and is a Regulatory Project Manager. He is involved with :

• Project analysis and implementation.
• Vendor selection and management.
• Project planning and project launches.
• Submissions, strategies and Agency interaction.

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 healthcare 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 also worked as an adjunct professor at Eastern Michigan University.

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.  Michael is also RAC certified through the Regulatory Affairs Professional Society (RAPS).

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.

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
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.

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. CQA RAC

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.
• 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 worldwide. 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 25 years experience in the industry and has been with RAA since 2005. She was Regulatory Compliance Manager and ISO Management Representative at Ferndale Labs prior to joining RAA and also served as Quality Assurance Auditor and Senior Regulatory Affairs Associate at Schwartz Pharma Manufacturing.

Deborah 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. She is also a member of the American Association of Pharmaceutical Scientists and the American Chemical Society.

Diane Whitworth M.L.S.

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.

E Mitchell Seymour Ph.D.

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.

Robert Monteith

Robert Monteith, 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.

Amy Earl, Mba

Amy Earl serves as RAA’s Operations Manager.  She assists in all aspects of project implementation and project management ensuring client needs are met and expectations are exceeded. 

Amy is also the Office Administrator for RAA.  She oversees the daily operations of the business including billing, payroll, appointment setting, record keeping, database management and travel arrangements.

Prior to joining RAA, Amy worked in purchasing, procurement and product management for a variety of industries including county government, live goods, automotive and industrial supply.

Ms. Earl earned her Master of Business Administration, from Walsh College of Accountancy and Business Administration; where she graduated Cum Laude.  Her Bachelor of Science in Business Administration was earned at Central Michigan University, where she concentrated in International Business and minored in Business Law.