xFDA consulting provides contract services for the approval of Drugs, Biologics and Medical 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. We offer a wide range of advice and services from preclinical trials, drug, biologic and medical device development, clinical trial protocols and support through the approval process and beyond. xFDA has inspectors who can audit your facility and give you a gap analysis. xFDA can also assist with non-prescription drug products (over-the-counter).
xFDA consultants have extensive experience consulting on FDA affairs because they were experts at the FDA. They consult in the areas of human and veterinary medicine, toxicology, chemistry, pharmacokinetics, pharmacology, microbiology, statistics, and bioequivalence. xFDA has device consultants who specialize in FDA approval of various types of medical devices. Many of our consultants have also worked in the pharmaceutical or device industry.
xFDA has FDA compliance consultants for mock inspections, audits and label reviews. xFDA offers FDA - GMP, GCP and GLP inspections.
Our FDA consultants listen to clients' needs and plan a drug development program specific for that firm's project. Our experts can draft regulatory submissions for firms or can review their regulatory submissions before submitting to the FDA.
xFDA experts can advise firms with generic bioequivalence issues to help determine what studies will be required for proposed drug product. We can advise on analytical methods, stability and other issues involved in the ANDA process.
xFDA has an MD/MPH who can assist your company with pharmaceutical post approval issues. xFDA chemists and statisticians can also assist you with pharmaceutical post approval stability protocols.
With the appropriate design of experiments our FDA consultants can focus on getting your product to market as rapidly and safely as possible sparing you costly delays caused by misunderstanding of what is required for your specific project.
We serve a range of clients, from small startups to large pharmaceutical and medical device companies. xFDA can also teach, guide and serve as an auditor and peer reviewer. xFDA is flexible and can supply parts of a team if a company is in need of only certain expertise.
Experts in Class I, II, and III devices, test kits, 510 (k)s, quality engineering issues (all of 21CFR820), software validations (including 12CFR11), human factors validations, risk management and risk analyses.