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Obelis Group is a trusted regulatory partner, supporting market access for medical devices, cosmetics, food supplements, and other sectors across the EU, UK, US, Switzerland, Canada, and TΓΌrkiye.
Obelis Group is a leading regulatory compliance specialist, dedicated to accelerating your market access worldwide. With extensive experience in the EU, UK, US, and Switzerland, Obelis provides expert guidance and comprehensive services for a wide range of industries, including Medical Devices, Cosmetics, Toys, Food Supplements, and Motor Vehicles. We act as your Authorised Representative and Responsible Person, ensuring your products meet all local regulatory requirements. Our services encompass formula review, labelling compliance, claims verification, product registration, technical documentation management, and communication with regulatory authorities. Whether you are navigating the complexities of the EU General Product Safety Regulation (GPSR) or ensuring your toys meet stringent safety standards, Obelis offers tailored solutions. Obelis also provides specialized training programs to help your team master EU compliance requirements for cosmetics and medical devices. Our flexible training options, including in-house, online, and on-demand modules, empower your staff with the knowledge and tools needed for successful market entry and sustained compliance. Partner with Obelis to confidently bring your products to international markets while mitigating risks and building consumer trust.
HQ:
Brussels, Belgium
Jurisdictions:
EU, UK
Languages:
English, French, Dutch, German
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International Associates provides expert regulatory compliance services, acting as Authorized Representatives and Responsible Persons for manufacturers worldwide.
International Associates Limited is a UK-based firm offering specialized regulatory compliance services to manufacturers seeking to place their products on the EU and UK markets. They act as appointed Authorized Representatives and Responsible Persons, ensuring adherence to directives and regulations such as the EU Cosmetics Regulation (EC) No 1223/2009 and the UK Cosmetic Products Enforcement Regulations 2013. With expertise in various product categories including cosmetics, toys, medical devices, and general product safety (GPSR), International Associates helps international manufacturers navigate complex legal landscapes. Their services are crucial for companies based outside the EU or UK, providing a local point of contact and ensuring all mandatory tasks and documentation requirements are met. They offer a cost-effective route to certification and compliance, backed by a mission to empower global communities through exceptional services in supply chain management, ESG, regulatory compliance, quality management, and sustainable business solutions. Their commitment to ethical standards and innovative practices drives growth and delivers value to clients and stakeholders worldwide.
HQ:
Glasgow, United Kingdom
Jurisdictions:
EU, UK, CH
Languages:
English
Pricing model:
Per project
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At QLE Group, we're all about making the complex world of medical device regulations simple for you. Our team is here to guide MedTech companies through the maze of CE Marking, Quality Management Systems (QMS), FDA submissions, and thorough audits. We're dedicated to ensuring your products don't just meet, but exceed global standards.
Services
CE Marking: Smooth pathways to get your products into the European market.
QMS Implementation: Strong systems that meet ISO 13485 and 21 CFR 820 standards.
FDA Submissions: Smart strategies for different types of FDA approvals.
Audits: Benefit from our exacting assessments tailored to scrutinize and improve your internal and supplier practices.
Our Approach
We believe in a personalized touch, ensuring each client gets exactly what they need with smart planning and deep industry knowledge. Our team's expertise in regulations and the MedTech sector means we deliver solutions that push healthcare forward.
Why Choose Us
Expert Guidance: Our consultants are seasoned pros with a history of success.
Customized Solutions: We tailor our services to fit your specific needs.
Strategic Partnerships: Work with us for a smooth journey from idea to market.
Join our community to keep up with the latest in regulatory news and see how we can boost your MedTech business.
Jurisdictions:
EU
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ELS Group is a company with deep technical expertise and market access in Regulatory Affairs and Quality Assurance, duly certified. With 18 years of experience, we provide strategic solutions.
HQ:
Estoril, Portugal
Jurisdictions:
EU, UK, CH, US, BR, Global, OTHER
Countries:
EU-wide;UK;CH;US;BR;GLOBAL
Response SLA:
24 hours
Pricing model:
Custom pricing
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MDSS is a leading European Authorized Representative (EC REP) with over 30 years of experience, specializing in regulatory affairs for medical and in-vitro diagnostic devices. They offer comprehensive in-country representation services across the EU, UK, Switzerland, USA, and Australia.
MDSS GmbH, established in the European Union, is a trusted Authorized Representative (EC REP) with over 30 years of experience in providing In-Country Representation and specializing in Regulatory Affairs for Medical and In Vitro Diagnostic Devices. They are recognized as a leading European Authorized Representative, serving clients for over two decades from the same trusted address. MDSS offers comprehensive In-Country Representation services across the EU, United Kingdom, Switzerland, USA, and Australia. They act as European Authorized Representative, UK Responsible Person, Swiss Authorized Representative, and U.S. Agent, allowing non-EU based companies to focus on their core business, including innovation, while ensuring compliance with regional regulations. Specifically for the EU market, MDSS assists with EU Registration with the European Authorities. They are crucial for non-EU based Medical Devices Companies needing to appoint an EU Authorized Representative to place devices on the EU market, as mandated by regulations like MDR (EU) 2017/745 and IVDR (EU) 2017/746. MDSS also provides representation for compliance with the AI ACT and the General Product Safety Regulation (GPSR). Furthermore, MDSS acts as an EU Representative for the General Data Protection Regulation (GDPR) for processors and controllers operating outside the EU who handle personal data of individuals within the EU. They ensure compliance with Article 27 of the GDPR, acting as a point of contact for supervisory authorities and data subjects.
HQ:
Schleswig-Holstein, Germany
Jurisdictions:
EU
Languages:
English, German
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Euverify provides automated compliance tools and GDPR Representative services to help businesses meet EU/UKCA regulations. Streamline your compliance journey with expert guidance.
Euverify offers a comprehensive platform designed to simplify your compliance journey. Their services include automated compliance tools for EU/UKCA regulations, helping you generate necessary declarations and understand complex requirements. They also provide a GDPR Representative Module, assisting businesses in meeting their obligations under GDPR. The Euverify Help Center offers step-by-step guides, feature explanations, and answers to common compliance questions, ensuring you can efficiently manage your account, appoint authorized representatives, and keep your products legally compliant. Whether you are new to compliance or switching systems, Euverify aims to make the process seamless and efficient.
HQ:
London, GB
Jurisdictions:
EU, UK
Languages:
English
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CE.way offers regulatory and testing solutions for cosmetic products in the EU, UK, and other markets. Services include EU/UK Responsible Person, CPNP/SCPN notifications, PIF management, CPSR, safety and efficacy testing, and GPSR compliance. In-house lab for stability, challenge, microbiology, and SPF testing. Members of Cosmetics Consultants Europe, Society of Cosmetic Scientists, and CTPA.
At CE.way we help you bring your cosmetic products to the market quickly and efficiently. With a combination of our know-how and in-house lab facility, we offer regulatory consulting and testing services and seamlessly navigate you through the registration process in the European Union, United Kingdom, USA, USA OTC, Canada, ASEAN, China, Saudi Arabia, UAE, Gulf Cooperation Council, India, and other markets. Services include: EU & UK Responsible Person (RP), CPNP/SCPN notifications, Product Information File (PIF) compilation and maintenance, formula compliance, safety assessments (CPSR), stability and compatibility testing, challenge testing, microbiology testing, efficacy testing, GPSR (General Product Safety Regulation) compliance, and European representative for companies not located in Europe. We perform safety and efficacy testing in our own in-house laboratory using state-of-the-art techniques and consumer perception tests.
HQ:
Dublin, EU
Jurisdictions:
EU
Countries:
SI, AT, DE, FR, IT, NL, GB, IE
Languages:
English
Response SLA:
48 hours
Onboarding time:
2β7 days
Pricing model:
Retainer
Starting from:
EUR 350
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