Regulatory writing

We work in partnership with your team to help you deliver high-quality regulatory documents.

Our approach

We have a flexible approach and aim to surpass our clients’ expectations by being trusted experts in our field.

We have the skills and expertise to interpret and summarise complex data, producing high-quality, concise content that complies with regulatory guidance.

Our highly experienced regulatory writers integrate seamlessly with your team to ensure your clinical documentation is delivered to the highest standards.

Our expertise covers

The full range of clinical regulatory documents, including:

Protocols

CSRs

Narratives

CTD submission modules

Regulatory responses

Briefing packages

Medical device documentation

Transparency and disclosure services

Protocols

CSRs

Narratives

CTD submission modules

Regulatory responses

Briefing packages

Medical device documentation

Transparency and disclosure services

Why choose us

Document-specific expertise

Flexible and reliable solutions

Delivery to high-quality standards

Speak to our team

What impressed me most was the ownership that you took of the clinical documents. We trust our suppliers implicitly to lead the submission process, and you have more than fulfilled that trust. Thank you again and congratulations!

Director

Global Medical Communication

We very much enjoyed working with you and felt you were excellent value. You seem to have the big picture and an eye for detail and were incredibly committed.

Regulatory Affairs Director

Europe & Canada

My experience collaborating with your writers has been just amazing! They are extremely pro-active, very committed and consummate professionals. Working with them has been very smooth and transparent and I look forward to continue working with them.

Associate Director

Clinical Regulatory Writing

Other services

Strategic planning

We use unparalleled depth of knowledge, insight and years of combined expertise to discover what’s ‘next’ so we can apply it to the ‘now’.

Medical communications

We apply rigorous principles of scientific research and strategic thinking to all our processes.

Market access

We establish the right access strategy, evidence-based value stories and supporting communication tools.

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