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Regulatory Affairs Services

Q: Can you offer support in developing a clinical strategy at an early stage?

Yes! We can support you in developing clinical strategies at whatever stage they’re currently at. By working with you, we can craft tailored strategies that align with your regulatory expectations and maximise the potential for successful clinical trials.

Q: Which countries can you help cover in terms of licence management?

Our services can be tailored to your specific requirement to offer support in a wide variety of different countries and markets around the world, including the UK, EU and US.

Q: Do Apotech provide Qualified Person (QP) and Responsible Person (RP) services?

Yes, we offer Qualified Person (QP) and Responsible Person (RP) services and have the expertise required to ensure compliance with regulatory requirements. Check out our QA services page.

Bringing a medical product to market is incredibly complex. But, at Apotech, we have the skills and knowledge required to ensure complete regulatory compliance during both its clinical development and the entire project life cycle.

EU Regulatory Submissions

Medical Writing

FDA Submissions

Life Cycle Management

Trusted expertise from drug development to life cycle management

Helping you navigate through clinical trials and authority approvals

At Apotech, we specialise in guiding pharmaceutical and biotech products through the complex regulatory world involved, from Clinical Development through to Marketing Authorisation Life Cycle Management

With expertise spanning both EU and US regulations, our services align with the rigorous standards outlined by the FDA, EMA and many other key international regulatory bodies, and are designed to ensure a smooth, compliant path when bringing medical products to market.

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Pharma and Biotech Regulatory Affairs FAQs

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Trusted by top-tier teams worldwide

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Services designed to deliver complete compliance

We understand how crucial regulatory compliance is in the pharma and biotech industries, not only to gaining approval for clinical trials but to also eventually marketing your medicines and products.

That’s why we are always here to lend our expertise. Whether you need specific regulatory support during a product’s clinical development journey or advice on how to handle post-approval modifications, we can tailor our services to help in any way you need.

FAQs

We aim to make the process as simple to understand as possible and are always on hand to answer any questions you might have.

Here are some of the questions we get asked most often.

What experience do you have with ATMP clinical development?

Our team has extensive experience in Advanced Therapy Medicinal Product (ATMP) clinical development and is well-versed in how to deliver compliance throughout the development process. Get in touch with us for further information.

Can you offer support in developing a clinical strategy at an early stage?

Which countries can you help cover in terms of licence management?

Do Apotech provide Qualified Person (QP) and Responsible Person (RP) services?

Featured case studies

Global in-country regulatory support

510(k) Submission Introduction Top 3 Global CRO Our client is one of the largest CROs globally, with operations present in every economy. Their services range from Clinical Development, Medical Affairs, and Commercial Delivery. Apotech continues to partner with them on a 3-year FSP contract. Apotech’s Consultants Our 18 strong Consulting team includes a mixture of…

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