X-FDA Consultants

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Steve was a former FDA Investigator and has both FDA and industry experience. His expertise is with Class III medical device products from regulatory strategy development through pre/post requirements. He performs Mock-FDA audits for medical devices, Human Tissues and complex high risk (HACCP) foods.   

He is experienced with writing technical documents required for US and EU PMA/510k submissions and has expertise with ISO 13485. Steve has also helped firms build quality systems that have passed FDA scrutiny. He holds a BS in Molecular Biology from the University of Colorado.

Jennifer has more than 18 years combined FDA and Industry experience with Pharmaceuticals, medical devices, biologics and bio-research clinical regulatory requirements.  During her 10 years tenure with FDA, she conducted many inspections covering all product areas and was considered expert in BIMO, GMP and GCP audits.    

Jennifer is considered an expert in assessing compliance issues and implementing corrective actions/quality systems to resolve problems.  She holds a Bachelor of Science degree from Florida State University.​

 John Crowe is a retired FDA Investigator and forensic chemist with more than 33 years of combined FDA and industry experience in pharmaceuticals, BIMO, laboratory compliance and dietary supplement audits.  He has expertise in implementation and interpretation of FDA regulatory requirements and is considered an expert in BIMO.  John is knowledgeable in quality systems and can conduct mock FDA inspections regarding pharmaceuticals, BIMO, dietary supplements, laboratory and corrective action implementation.  

John holds a Bachelor’s degree in Forensic Chemistry from Eastern Kentucky University.  As a research chemist with the FDA’s Forensic Chemistry Center, he was involved with the implementation of the FDA’s tobacco regulations, as well as a lead chemist with: melamine in pet food; over-sulfated heparin; counterfeit drug and packaging identification; Ma Huang; and hundreds of other formulation issues with dietary supplements. John has been published over 20 times in internal and peer review journals and is an accomplished researcher and problem solver.

Dr. Mastronardy has more than 25 years both FDA and Industry experience. He is an expert in providing guidance to regulatory submissions (ANDA, NDA, PMA, 483 response, consent decrees, supplements, annual reports) and writing regulatory SOPs.  He worked in the Generic Drug Division while serving the FDA.  

Dr. Mastronardy has quality system expertise regarding cGMP solutions for both pharmaceutical and medical devices.  He conducts validity assessment audits and assists in developing QC (laboratory) specifications & method validations. He is known for his ability to assess issues timely and implement quality systems that work (pass FDA scrutiny). 

Dr. Mastronardy has a Bachelor’s degree in Biology and a Ph.D/M.S Genetics.

Alex Slizza is a former FDA Investigator with 20+ years combined FDA and Industry experience. His expertise is in the medical device (QSIT) and biotech areas. 

During his FDA tenure he was a member of the International Inspection Cadre.

Alex holds a Bachelor of Science, Bioengineering degree from the University of California.

Nancy is a former FDA prosecutor, defense lawyer and trade association executive with more than 20 years experience in training FDA and industry officials.  She created the course: Dangerous Documents - Avoiding Land Mines in your FDA Records and Emails to make people aware of how prosecutors, plaintiff lawyers, and the media can infer inappropriate conduct from short, cryptic and sarcastic emails.  She has presented the course at 75 drug and device companies, FDA staff college, public seminars and universities. 

Nancy received her BS from Cornell University and her JD and LLM from New York University Law School. She received Vice President Gore's Reinventing Government Award, the FDA Commissioner Special Citation and was selected as one of the 100 most notable people in the medical device industry.