Head Office
The Ropewalks
Newton Street
SK11 6QJ, UK

+44 (0)3332224269

Bioscript Science LLC
103 Carnegie Center
Suite 300
Princeton, NJ 08540 6235 

+1 (609) 664 9973

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Regulatory writing

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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:

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

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!


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

A breadth of capabilities

By combining global cross-functional working, specialist knowledge and tech-enabled insights, we help our clients streamline their scientific strategy and enhance patient access.

Find out more


Start your journey with us
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