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.

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RA QA Compliance
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We’ve been there and done that!

Extensive experience with FDA compliance, including the issuance of numerous Warning Letters, seizures, injections, and the review of responses to FDA-483.

FINDING THE RIGHT FDA CONSULTING FIRM

Finding the right 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 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:

    • 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.

FDA CONSULTING BY EX-FDA

Whether you have recently started a company or have hired new quality staff, compliance with the FDA laws and regulations comes first. If you have doubts and want to examine your quality manual in greater depth, RAQA is here. We can also conduct mock FDA inspections to review and align your compliance with the CGMP or ISO.

No matter what your issues are, we can help you in time.

However, please don’t wait until the FDA knocks on your door. Instead, allow our former FDA investigators to look closely at your CGMP and make appropriate corrections.

Human & Animal Health Industries

Quality should be your top priority for every manufacturer that handles products related to human and animal health. Because the FDA never inspected your facility, it doesn’t mean you don’t have to comply with the United States Federal Food, Drug, and Cosmetic Act. Even though the FDA has not inspected your company for the past 20 years, it doesn’t mean you are not under their radar. Your firm may be the lower priority in their work schedule, but the FDA monitors and comes when they deem necessary. Therefore, being ready all the time is your responsibility.

Approximately 25% of the products we use or buy daily are FDA-regulated.

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Today is the time, not tomorrow.

Please note that because you are certified in ISO 13485, it doesn’t automatically comply with 21 CFR 820. Let us come in and evaluate your compliance with the new regulation.

“Quality Culture” FDA Consulting

As a medical products manufacturer, FDA compliance should not be your rationale for establishing a quality system. Simultaneously, you can ignore the quality because you don’t export products to the USA. Quality should be “built-in” as long as you handle medical products regardless of the regulations and laws. As such, we call this the “quality culture.” In other words, you should adopt a quality system for your company, regardless of compliance, laws, and regulations issues. Moreover, it involves everyone, departments, and the process of handling medical products.

What are the FDA laws?

The U.S. FDA regulates medical products through various laws and regulations. The main statutory laws are the Act and 21 CFR. Additionally, the FDA publishes guidelines documents that reflect their interpretations. At RAQA, our consultants are trained and experienced in the application of these laws and regulations.

What Is The Current Good Manufacturing Practice (CGMP)?

The CGMP is outlined in the 21 CFR, Code of Federal Regulations, Title 21. Relevant manufacturers must adopt customised good manufacturing practices for their unique manufacturing processes. Therefore, duplicating other manufacturers’ CGMP may not be adequate. We have been there in an official capacity. As such, we understand better what officials expect when they come to your manufacturing plant. In addition, we pass our experiences and knowledge on to your quality staff.

You Can Better Prepare For An Upcoming Audit By Choosing FDA Consulting.

However, it’s prudent to be proactive, so you’ll have plenty of time to correct any deficiencies identified during the mock FDA inspection. Waiting until you receive notification of an upcoming inspection from the FDA may not have ample time to identify and fill the gaps in the quality system.

The Purpose Of Our FDA Consulting

  • First, your quality system must be flawless to succeed and lead in today’s aggressive and competitive market.
  • Our experienced ex-FDA investigators are in the most qualified position to consult on FDA matters.
  • It’s the most beneficial, inexpensive way to go through an FDA inspection.
  • A strategic way to train your staff is to be psychologically prepared for FDA inspections.
  • Finally, avoid non-compliance history; someone can use them against your company.

Medical Device And In-Vitro Diagnostic (IVD) Manufacturers

The Code of Federal Regulations CFR, Part 21 Section 820, also known as Quality System Regulation (QSR). The inspection method is the Quality System Inspection Technique (QSIT). US FDA adopted QSR in 1997 to help medical device manufacturers comply with 21 CFR 820.

By enacting The Federal Food, Drug, and Cosmetic Act, Congress gives the FDA authority to monitor the safety of food, drugs, medical devices, and cosmetics. For some, this Act is a challenging and complex US law. Nonetheless, it governs your medical products. That’s why you will need our FDA consulting services.

What’s New QMSR?

It is the revised part 820 of the Quality System Regulation (QSR). On August 7, 2024, the FDA published the Quality Management System Regulation (QMSR): Final Rule Amending the Quality System Regulation, which is in effect on February 2, 2026.

It aligns closely with the international consensus standard for Quality Management Systems of medical devices recognised by many regulatory authorities worldwide. However, the FDA has yet to develop a new inspection process as of writing this section. At RAQA FDA Consulting, we understand how you can prepare to meet the new regulations that affect you.

Please don’t wait until you get a notification of an FDA inspection before consulting with us.

Not all former FDA employees possess the expertise you need.

Hiring former FDA officials with extensive FDA backgrounds for your organisation may be out of reach. Just because of ex-FDAers doesn’t mean they meet the job qualifications. This is where our FDA Consulting comes in convenient. We have an expansive background in the FDA to consult with every question, be it the laboratory, regulatory, CAPA, compliance, inspection, quality management, regulatory submissions, corrective actions, recall, or validations.

In addition, we can comprehensively examine and align your quality system with FDA regulations and other requirements. In fact, our mock inspection is designed exclusively to examine and test your company’s quality policy to reveal any gaps or problems before an FDA inspection.