Medical Writing

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.

Apotech has a comprehensive range of services related to regulatory writing and support for both clinical and nonclinical development. These services cover various aspects of regulatory submissions, documentation, and compliance across different regulatory authorities.

Regulatory Writing Support:

Tailoring support based on submission type and regulatory authority requirements

Nonclinical & Clinical Documentation:

Clinical Study Report (CSR)
eCTD Modules 2.4, 2.5, 2.6, and 2.7
eCTD Modules 4 and 5

Clinical Trial Support:

Clinical Trial Protocol (CTP)
Investigator Brochure (IB)
Efficacy and safety summaries
Patient/safety narrative writing

Integrated Summaries:

Support on Integrated Summaries (ISS, ISE, and ISI)

Scientific Writing Services:

Publication, abstract, poster, brochure, presentation preparation
Literature searches and reviews

Toxicological Risk Assessment:

Assessment of impurities, extractables & leachables, excipients, and industrial chemicals
Occupational Exposure Level (OEL) calculations

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FAQs on quality assurance

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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

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…

Regulatory Strategy IVDR / FDA

Regulatory Strategy IVDR / FDA Introduction Deciphex Deciphex is a digital pathology workflow and integrated AI platform for research pathology, CROs and pharmaceutical companies for handling high volume drug safety pathology studies. They provide a complete GLP-compliant workflow with integrated AI screening capabilities. Standards & Tools Scope of work Brian – Director QA RA As…

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…

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