Subject matter expert (SME) in FDA Compliance
FDA Regulatory Consulting
Welcome to RAQA, an FDA Regualtory Consulting firm, also known as your regulatory resources by ex-FDA scientists, reviewers, investigators, compliance officers, and managers. We are subject matter experts (SMEs) in the regulatory and quality field to detect non-conformance, assess, analyse, and prevent adverse effects of medical devices, in-vitro diagnostics, biologics, and pharmaceutical drugs.
We’ve been there and done that!
FINDING THE RIGHT FDA CONSULTING FIRM
Finding the right FDA consulting firm for your industry is more challenging than you might think. There are many corporate and independent consulting companies out there, and each promises excellent results. However, as drug, biologics, or medical device manufacturers, it’s ultimately your responsibility, regardless of the outcome. Therefore, finding a proper regulatory FDA consulting firm for your needs is critical.
At RAQA, we have both FDA and industry experience. We understand and have expertise on both sides. We can “think” like the FDA, from mock FDA inspections to regulatory submissions.
OUR FDA CONSULTING SERVICES INCLUDE:
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- Mock FDA Inspections – Medical Device QSR, Drug CGMP, OTC, Cosmetic, GLP, GCP, HACCP, ISO, and Animal Drug & Feeds.
- Present during an FDA Inspection
- Suppliers Vendor Quality CGMP Audits
- Recalls, removals, and field corrections
- Regulatory submissions (Premarket Notification (PMN) 510(k), PMA, NDA, ANDA)
- Submission of a food additive petition for approval
- Review Warning Letters (WL) and FDA-483, Inspectional Observations, responses
- CAPA (Corrective and Preventive Actions)
- CGMP, ISO, QSR Training
- Registrations and Listing
- Review standard operating procedures (SOPs) and quality system manual
- Label & labelling reviews, including websites and dietary supplements
- Quality Management System (QMS)
- Validations: computer system, water for injection (WFI), purified water, sterilisation, cleanroom, aseptic filling, formulation, process & automation, software, and packaging.
Furthermore, finding quality staff with FDA experience is particularly challenging. Designate us for all your FDA-related needs. The location of your manufacturing facility is not a concern since we are conveniently located in Asia and Europe. For short-term mock FDA inspections or long-term FDA consulting, contact us today.
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