Regulatory Affairs Services

Regulatory affairs plays an essential, multifaceted role in the life sciences. It serves as the bridge between scientific innovation, business objectives and regulatory compliance. FDAQRC is your reliable partner for pharmaceutical, biotech and medical device regulatory affairs, providing specialized consulting in more than 70 countries since 2009.

Our extensive global consultant network encompasses hundreds of active consultants covering all GxP areas. We bring clarity and expertise, helping you ensure products are developed, manufactured and distributed in accordance with the laws and regulations of the relevant regulatory authorities worldwide.

Our Core Regulatory Compliance Services

FDAQRC offers dedicated global regulatory affairs services encompassing strategic, tactical and operational support to ensure products meet all necessary regulatory standards from conception through post-market life. Our tailored solutions adapt to your specific requirements for product safety, efficacy and quality, facilitating market access and mitigating regulatory risks.

Clinical Support and Development Operations

FDAQRC has ample expertise in guiding clients through the regulatory requirements for clinical trials and product development. Our experts help you ensure compliance with standards like Good Clinical Practice (GCP) and Good Clinical Laboratory Practice (GCLP). Our clinical and laboratory compliance solution streamlines the development process, supporting quality management from initial strategy to operational execution.

United States FDA Regulatory Consulting

FDAQRC has profound knowledge of U.S. Food and Drug Administration (FDA) regulations. Our consultants specialize in various submission types, including Premarket Approval (PMA), 510(k) submissions and De Novo Classification for medical devices. 

We also support In Vitro Diagnostic Device (IVDD) compliance, guiding and assisting clients in preparing and submitting the necessary regulatory applications, developing strategic regulatory pathways and more. Our remediation services deliver focused, inspection-ready solutions for FDA Warning Letters and Form 483 observations.

European Union Regulatory Affairs

FDAQRC offers tailored EU regulatory affairs solutions. Our experts provide guidance on Medical Device Regulation (MDR), In Vitro Diagnostic Regulations (IVDR), Periodic Safety Update Reports (PSUR) and European Database on Medical Devices (EUDAMED) consulting, ensuring seamless market access and post-market surveillance in Europe.

We also provide Qualified Persons (QP) services for UK and EU drug releases. FDAQRC  has the expertise and certified personnel necessary for the final critical regulatory sign-off that allows drug products to be released for sale or supply in the region, specifically focusing on imported pharmaceuticals.

Why Partner With FDAQRC for Regulatory Affairs?

FDAQRC offers unparalleled experience, global reach and a network of specialists to help you reach excellence in regulatory compliance. Our extensive international presence allows us to support companies navigating regulations across diverse markets. We offer a wide range of specialized services and take a tailored approach, acting as an extension of your internal teams for risk-based execution and long-term compliance stability.

When you partner with us for your regulatory affairs needs, you can expect:

  • Global expertise with deep regional specialization
  • Proven remediation and crisis management capabilities
  • Access to a network of seasoned industry and regulatory experts

Connect With Our Regulatory Affairs Specialists

Ensure your product’s success with FDAQRC’s unparalleled Regulatory Affairs expertise. Fill out our contact form for a consultation and navigate the regulatory landscape with confidence.

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