FDA Submissions and Reviews

Contract Services / Review and Advisory

QA RA consulting provides contract services for the approval of drugs, biologics and medical devices by the Food and Drug Administration (FDA).

QA RA consists of consultants, formerly FDA experts, involved in the drug, biologic and medical device approval processes.

We offer a wide range of advisory and services from pre-clinical trials, drug, biologic and medical device development, clinical trial protocols and support through the approval process and beyond.

QA RA has inspectors who can audit your facility and give you a gap analysis. 

QA RA can also assist with non-prescription drug products (over-the-counter).

Our Experience

QA RA 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. 

QA RA 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.

Compliance and Inspection

QA RA has FDA compliance consultants for mock inspections, audits and label reviews. 

QA RA 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

QA RA 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

QA RA has an MD/MPH who can assist your company with pharmaceutical post-approval issues. 

QA RA 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.    

QA RA can also teach, guide and serve as an auditor and peer reviewer. 

QA RA is flexible and can supply parts of a team if a company needs only certain expertise.