Staff | William G. Nychis

Position: Senior Regulatory Advisor

Bill Nychis

As a Senior Regulatory Advisor with Benjamin L. England & Associates, LLC and FDAImports.com, LLC, Mr. William G. Nychis provides comprehensive FDA regulatory assistance to companies marketing or distributing FDA-regulated goods in the United States.

Mr. Nychis has nearly 40 years of experience at FDA serving in a wide range of capacities, with special emphasis on compliance issues related to human drug, cosmetic, and dietary supplement industries. His extensive FDA background includes compliance and enforcement work in drug import/export issues, jurisdictional questions pertaining to combination products relevant to drug/device, drug/dietary supplement, and drug/cosmetic determinations.  He has a wide experience reviewing, recommending and overseeing FDA regulatory matters relating to human drug, veterinary medicine, food and dietary supplement compliance.

Trained as a chemist and microbiologist, Mr. Nychis has hands-on experience evaluating a wide range of FDA compliance questions such as Rx and OTC drug marketing materials for FDA compliance, human drug label reviews from FDA’s compliance perspective, all regulatory questions governing the import and export of human drugs and drug components, practice of pharmacy issues, and homeopathic drug product marketing requirements.  Mr. Nychis is an accomplished trainer, and has conducted dozens of sessions for thousands of FDA field investigators and drug industry personnel on the regulatory requirements of importing and marketing human drugs.  Mr. Nychis drafted numerous guidance documents, Import Alerts, and policy documents for FDA.

Additionally, Mr. Nychis has handled dozens of civil cases for FDA.  He worked with FDA’s attorneys and the U.S. Attorney’s office to identify expert witnesses, draft interrogatories, and prepare expert witnesses for testimony.  Mr. Nychis has been accepted by both federal and state courts as an expert witness for both civil and criminal cases.

Mr. Nychis holds B.S. degrees in Chemistry and Microbiology from the University of Pittsburgh, and has completed extensive coursework at the Masters level.