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Regulatory Affairs Services
Navigating the complicated world of IVD regulations can be tricky. But it’s also crucial to ensure successful market entry and compliance. Each of our services is designed with this in mind, helping you deliver seamless regulatory submissions and outcomes.
Delivering regulatory success to IVD manufacturers
Prioritise patient safety and compliance in global markets
At Apotech, we recognise the importance of regulatory affairs within life sciences. That’s why our strategic approach is grounded in expertise, providing you with all the tools you need to not only ensure regulatory compliance but also prioritise patient safety.
By integrating regulatory considerations early on in the development phase, we can guide you through complex approval processes, guaranteeing that your devices meet rigorous quality and safety benchmarks.
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Trusted by top-tier teams worldwide
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Bespoke regulatory solutions tailored to your needs
At Apotech, we maintain the highest standards to protect and uphold the regulations required to develop IVD devices.
Thanks to our structure, we can respond to changing conditions and customer requirements,
offering tailored regulatory solutions that you can rely on.
Our solutions are tailor-made to meet the unique needs of each client, offering a personalised approach to support you with your regulatory affairs.
Our team is made up of highly skilled consultants with diverse expertise, including former regulatory agency professionals. Thanks to this knowledge, we can offer effective guidance to help you achieve successful regulatory outcomes.
With the know-how to support a wide variety of projects, we offer a full spectrum of activities to support you throughout the entire IVD development cycle.
With headquarters in London and Paris, our offering extends worldwide. We also specialise in supporting non-EU businesses, leveraging our network of industry experts around the world to navigate international regulatory landscapes.
Excited to work together on your next project?
Why choose Apotech for IVD Regulatory Affairs?
With former regulatory agency expertise to our name, our role extends beyond market entry.
From global submissions to post-market support, we offer a comprehensive range of services designed to help you establish trust, maintain your reputation and deliver compliant life sciences operations successfully.
FDA
ongoing projects with FDA (Breakthrough,
PMA, 510(k), Qsub)
EU MDR
Support to transition to
clients
UKCA Marking
Five ongoing submissions
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We offer a global reach
With more than 800 Lead Auditors across every major global country, we can offer bespoke guidance to support your auditing requirements.
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We offer a global reach
With more than 800 Lead Auditors across every major global country, we can offer bespoke guidance to support your auditing requirements.
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We offer a global reach
With more than 800 Lead Auditors across every major global country, we can offer bespoke guidance to support your auditing requirements.
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We offer a global reach
With more than 800 Lead Auditors across every major global country, we can offer bespoke guidance to support your auditing requirements.
FAQs on IVD regulatory affairs
Whether it be the difference between UKCA and CE Marking, or a notified body versus an approved body, we understand that the world of IVD regulatory affairs can be hard to understand at times. That’s why we aim to make the complex simple.
Here are some of the questions we get asked most often.
Featured case studies
EU-IVDR Technical File Remediation
EU-IVDR Technical File Remediation Introduction In Vitro Diagnostic Manufacturer Our client is a leader in high-quality, innovative diagnostic products for the determination of blood groups (anti-Duffy and anti-Kidd). They are located in the US with operations globally. Standards & Tools EU-IVDR 2017-746 ISO 13485 ISO 14971 GDPR Word Excel Powerpoint Scope of work Key numbers…
Breakthrough Program
Breakthrough Program Introduction IVD manufacturer The company is a highly innovative IVD manufacturer start-up. Their device is CE marked and the client was looking to obtain FDA approval for sale on the US market. Apotech Consultants One consultant worked part-time on the project. The main focus was to design the rationale to be eligible for…