profiles and submissions for review and endorsement by the authorities such as FDA and other International Regulatory Authorities. Regulatory Submissions xFDA Consultants provide... our clients direction through the entire regulatory submission process. Our consultants were Experts at the FDA and many have industrial experience. They have an excellent background...Regulatory Home About Us Team Services Clinical Quality Systems Regulatory Training Solutions Compliance Expert Witness Consultants Medical Officers Chemists Device Experts Patent...

FDA submission consultants Home About Us Team Services Clinical Quality Systems Regulatory Training Solutions Compliance Expert Witness Consultants Medical Officers Chemists..., audits and label reviews. xFDA offers FDA - GMP, GCP and GLP inspections. DRUG DEVELOPMENT/SUBMISSIONS Our FDA consultants listen to clients' needs and plan a drug development program... Devices by the Food and Drug Administration (FDA). xFDA consists of more than 70 consultants formerly FDA experts involved in the drug, biologic and medical device approval processes...

Chemists Home About Us Team Services Clinical Quality Systems Regulatory Training Solutions Compliance Expert Witness Consultants Medical Officers Chemists Device Experts Patent... products. As a chemistry, manufacturing and controls expert, reviewed IND and NDA submissions to market new drugs in the United States. Responsible for drafting monographs for OTC... years at the FDA and has been a consultant to the pharmaceutical industry since 2007. The expert holds a PhD in Medicinal Chemistry. Areas of expertise include inhalation and other...

FDA submission consultants Home About Us Team Services Clinical Quality Systems Regulatory Training Solutions Compliance Expert Witness Consultants Medical Officers Chemists... years. His experience with the US Government in high level positions of increasing responsibility include: Senior Consultant in the Office of Economic Opportunity - Office...

(click to read more) Home About Us Team Services Clinical Quality Systems Regulatory Training Solutions Compliance Expert Witness Consultants Medical Officers Chemists Device.... BA - Business Administration - Brooklyn College, Brooklyn, NY Marilyn A. Apfel, PhD Dr. Apfel is a former FDA CMC expert and is an expert in FDA regulatory submissions. She... of applications for FDA submission. She advises on analytical issues, impurities, clinical supplies and packaging issues, drug substance and drug product stability issues, and all facets...