CONTRACT SERVICES/REVIEW AND ADVISE
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 150 consultants formerly FDA experts involved in the drug, biologic approval and medical device clearance 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).
OUR EXPERIENCE
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 clearance of various types of medical devices. Many of our consultants have also worked in the pharmaceutical or device industry.
COMPLIANCE AND INSPECTION
xFDA has FDA compliance consultants for mock inspections, 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 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.
GENERIC DRUG PRODUCTS
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.
POST APPROVAL ISSUES
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.
SPEED TO MARKET
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.
LARGE AND SMALL CLIENTS
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.
We are here to serve you…
Physicians
Prepare the Clinical Section of the pre-IND Package, the IND and the NDA in the format familiar to the FDA.Pharmacologists
Detect and measure drugs and metabolites in animals and humans and plan studies for proof of principle.Pathologists
Design new preclinical paradigms. Interpret tissue responses through knowledge of tissue and organ homeostasis, regenerative biology, and translational medicine.Pharmacokineticists
Study the rate of drug uptake, circulation and elimination of active drug substance and metabolites to help decide on pursuing a potential drug product.Veterinarians
Preclinical studies in animals require knowledge of the test animals and how these tests should be conducted.Toxicologists
Examine or predict adverse effects of drugs on living organisms; carefully matches the proposed label claim with preclinical plans.Microbiologists
Sterile products need manufacturing facilities, techniques, and knowledge of how to describe them in the FDA application.Statisticians
Provide advice, and crucial council on the statistical aspects of clinical trial and stability studies; design experiments, calculate sample sizes, analyze results.Chemists
CMC involves proof of structure, specifications, impurity levels in drug substance and product, manufacturing controls, analytical method validation, packaging, and stability.Inspectors
BiMo, biologic, drug and device inspectors are available to inspect your facility. xFDA has GLP inspectors for animal laboratories . xFDA can examine your OTC product label for compliance with the regulations.Device Experts
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.