OUR CONSULTANTS HAVE FDA EXPERIENCE
xFDA is a group of FDA consultants who assist firms with drug, medical device, biologic development and regulatory affairs. We have physician, pharmacology, toxicology, chemistry, pharmacokinetic, veterinarian, pathologist, engineer, microbiologist, statistician, device, and inspector consultants. Our consultants all worked as experts at the FDA and were involved with approving products to be sold on the US market.

DEPTH AND BREADTH OF EXPERIENCE
xFDA experts can help with simple dosage forms such as immediate release tablets, more complex dosage forms such as controlled release products, biologics, combination drug products, and devices. We can help with 510(k)s and 505(b)(2)s. Our FDA experts can serve as your regulatory liaison to the FDA, and our FDA investigative consultants are available to assist firms with GMP, GLC, and GCP requirements and mock inspections.

DEVELOPMENT PLANS // PROTOCOL DEVELOPMENT//INSPECTIONS
xFDA can create a development plan for a new drug and can design your preclinical and clinical trials. Our CDRH medical device consultants are available to help firms with their medical device development plans. As with drug and biologic products, medical devices require oversight by the FDA.  The requirements for a specific medical device development plan depend on several factors.  For medical devices such as pacemakers, there is a medical device approval process at the FDA.   For devices associated with less risk, for example when a predicate device exists, a 510(k) can be submitted for clearance by the FDA.
• xFDA can help with CMC expert issues. 
• Our FDA toxicologists are available to devise studies or advise firms regarding their preclinical trials.
• Our FDA consulting practice includes assisting firms with pharmaceutical post approval marketing changes. 
• xFDA has OTC labeling consultants.
• For firms wanting an outside examination of their facility before FDA inspection, our xFDA investigative consultants will examine your facility as they would have when they were inspectors at the FDA.

Press Release

PatentProtectPlus(TM):
A New Service to Enhance and Strengthen a Patent Portfolio

xFDA Launches PatentProtectPlus to Strengthen Patents by Applying Innovative Know How and Technology.   Our Experts Have Experience Working With a Company's Patent Lawyers to Enhance the Company's Patent Portfolio and Defending the Company's Patents from Challenges by Industry Giants. Read more