Unlock smooth market entry and medical device regulatory compliance in the EU with AF Pharma's specialized consulting services. Our expert consultancy team provides comprehensive support for medical device technical documentation, Clinical Evaluation Report (CER) and medical device registration, ensuring a hassle-free path to success. AF Pharma is a reliable and experienced consultancy company for CE mark submissions where a Notified Body is involved, providing comprehensive support and expertise in regulatory compliance. Our knowledgeable consultancy team excels in navigating the intricate requirements set by Notified Bodies, ensuring a seamless process to register medical devices in Europe.
Moreover, if your organization has received warning letters from regulatory authorities, AF Pharma offers valuable guidance and assistance to address and rectify any regulatory and quality compliance issues. Count on AF Pharma as your dedicated partner in overcoming medical device regulatory challenges and achieving compliance effectively.
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Your Medical Device Authorized Representative and EU Importer
We provide EU Importer services, from our warehouse based in Spain
AF Pharma is a trusted partner specializing in regulatory solutions for a wide range of products, including Medical Devices, Cosmetics, Nutraceuticals, and general Health Products. As a highly reputable company, we proudly serve as both a UK Responsible Person (UKRP) and an EU Authorized Representative (EC Rep). AF Pharma provides comprehensive support as EU Importer to ensure medical device regulatory compliance and successful market entry.
With our extensive knowledge and experience, AF Pharma acts as a reliable medical device representative on behalf of manufacturers, bridging the gap between regulatory authorities and your company. As a UKRP, we navigate the complex landscape of UK regulations. By doing this we ensure that your medical devices meet the necessary requirements for market access in the United Kingdom. Simultaneously, as an EC Rep, we facilitate your compliance with European Union regulations, serving as a vital link between your organization and EU regulatory bodies.
At AF Pharma, our dedicated team of medical device regulatory professionals excels in providing tailored solutions for your specific industry. This also includes guidance on medical device regulatory strategy, technical documentation, and compliance requirements. We understand that each product category has its own unique regulatory challenges, and we are well-equipped to address the intricacies of Medical Devices, Cosmetics, Nutraceuticals, and general Health Products.
To receive a comprehensive quote for our services, including UKRP and EC Rep representation, or consultancy please reach out to us. Our experienced team will work closely with you, understanding your specific needs and delivering personalized solutions that ensure regulatory compliance, expedite market entry, and enhance your overall success. Trust AF Pharma to be your dedicated regulatory partner and unlock the full potential of your medical devices in the UK and EU markets, and let AF Pharma act as your EU Importer.
Services
CONSULTANCY
Generate your medical device regulatory documentation with AF Pharma's experts. Our technical writing services for Technical Files and Clinical Evaluation Reports (CER), ensuring meticulous compliance and clarity.
DEVICE REGISTRATION
Streamline your path to market entry in Europe with AF Pharma's comprehensive services for medical device registration, ensuring efficient medical device regulatory compliance and successful market access.
ISO 13485
Ensure adherence to ISO 13485 standards with AF Pharma's professional procedures writing services. Our expert consultants will optimize your quality management system and enhancing medical device regulatory compliance.