Where Confidentiality and Results Matter!
Global Regulatory Affairs, Quality Assurance, and Compliance Solutions
In today’s global era, hiring outside experts for your critical roles makes sense. Employing in-house specialists, especially in regulatory affairs, quality assurance, or compliance, can be undeniably taxing for start-ups, even well-established manufacturers. That’s where we come in. We have the experience, expertise, and resources to be your “RA/QA department.”
Our Comprehensive Services
We offer solutions to ensure your company meets global standards of compliance, such as the United States Food and Drug Administration (FDA), ISO, and European regulatory requirements.
Key Features of Our Services
Designate Your RA Functions
Our team of ex-FDA officials provides expert advice tailored to your specific needs, ensuring your company meets all regulatory requirements.
Comprehensive FDA Consulting
Medical Device, Drug, & Biologic
Our solutions are designed to fit the unique challenges of your manufacturing operations, ensuring seamless integration with your existing standard operating procedures.
Ongoing Support
We offer continuous support to keep your operations compliant with the latest laws, regulations, and standards.
Who We Are
Ex-FDA Investigators & Reviewers
We are ex-FDA Investigators, Compliance Officers, Reviewers, Laboratory Scientists, managers, and members of international medical device and drug inspectional cadres. Our experience, expertise, and knowledge of the FDA laws and regulations are at your disposal.
Medical Device & Pharmaceutical Industry Experts
We come from various medical device, biologics, IVD, combination products, HCT/P, and pharmaceutical manufacturers around the world. Our Regulatory Affairs and Quality Assurance advisors will go above and beyond to ensure a smooth transition of our partnership.
FDA Laws, Regulations, and ISO Experts
We specialise in the 21 Code of Federal Regulations (21 CFR), the U.S. Federal Food, Drug, and Cosmetic Act (The Act), Current Good Manufacturing Practice (CGMP), International Organization for Standardisation (ISO), CE marking, and the European Union MDR.
The margin of error is slim. Designate SME
Reach out to us today to learn more about our partnership or to schedule a personalised consultation with our experts.
Designate Your Regulatory Affairs, Quality Assurance, and Compliance Roles
Searching, hiring, and retaining proficient regulatory affairs specialists and compliance experts is challenging and, oftentimes, unaffordable. However, as a start-up medical device or pharmaceutical company in the United States or Europe, you can now designate all your Regulatory Affairs, Quality Assurance, and Compliance functions to our subject matter experts (SME) of former FDA Investigators, Compliance Officers, Reviewers, and medical device and pharmaceutical industry experts. This cost-effective but highly efficient solution will save you from the financial burden of maintaining an in-house RA/QA department as well as making unintended but critical mistakes. In addition, if you are in the United Kingdom and EU/EFTA member states or Schengen countries, our Europe Office is in Zurich, Switzerland, so travel expenses are minimal.
In addition, contact us if you need a customer service center for American consumers, you can outsource the CAPA-compliant call center to us. We can follow your Customer Complaint Handling standard operating procedures (SOPs), Medical Device Reporting (MDR) SOP, and other CAPA-related inputs.
Leading Experts in Quality, Regulatory Affairs, and Compliance
Our Mission
Our mission is to empower our clients to achieve excellence in medical device and pharmaceutical quality and regulatory compliance. We believe in fostering partnerships that drive innovation and ensure patient safety. Our expert consultants are not only experts in the field but also passionate about making a positive impact on our clients’ compliance and quality assurance practices.
About Us
Our RAQA Regulatory Firm is dedicated to guiding your company through regulatory compliance and quality assurance complexities. With decades of experience, our team is committed to ensuring that your products meet the stringent standards required by global health authorities. We pride ourselves on our comprehensive understanding of the regulatory landscape and our ability to tailor solutions that fit the unique needs of each client.