Regulatory Writing

Preparation of the documentation required at each stage of clinical development places a significant burden on clinical teams. Delay or failure to complete all the necessary key documents can have a significant impact on project timelines.

Give your development programmes a competitive edge by using our medical writing and clinical study management teams. They can integrate seamlessly with your clinical groups to facilitate information retrieval and rapidly incorporate it into clinical study documents. Our specialised regulatory writing services tailors to the specific needs of biotech and pharmaceutical sponsors, supporting drug development programs from early-phase clinical trials through to marketing authorisation. These services are delivered through a coordinated delivery package that integrates scientific expertise, regulatory insight, and document management best practices—ensuring clarity, compliance, and consistency across all submissions.
"I have found the Niche team to be knowledgeable and professional in approach, executing new work in a skilled manner and within required timelines."
Geoff Down
Director, Clinical Pharmacology and Discovery Medicine

GlaxoSmithKline
Regulatory writing support includes the preparation of a broad spectrum of clinical and regulatory documents. These services are embedded within our robust Quality Management System, which ensures each deliverable is produced under controlled conditions with traceable versioning, internal review, and sponsor approval processes. Our in-house editor works closely with the medical writing team to ensure that your documents meet the highest editorial standards. Our team can also be engaged on an ad-hoc basis as part of your internal document development and approval process.

Our end-to-end delivery approach supports both standalone writing projects and integrated clinical development programs. Our model is particularly well-suited to growing biotech companies that require experienced guidance and reliable document support, as well as larger pharmaceutical organizations seeking efficiency, scalability, and consistent quality in outsourced writing. Unlock the potential of your clinical development programme with our expert regulatory writing services. Developing regulatory documents that adhere to ICH guidelines and conform to requirements for e-submission/document management systems such as DocuBridge® can place a burden on company resources.

Unlock the potential of your clinical development programme with our expert regulatory writing services. Developing regulatory documents that adhere to ICH guidelines and conform to requirements for e-submission/document management systems such as DocuBridge® or Documentum® can place a burden on company resources.
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Frequently Asked Questions
With our decades of experience, we are ideally placed to advise on the content and process of writing regulatory documents. 

Our flexible delivery model and business structure allows us to offer timely advice and guidance regarding regulatory requirements. We have extensive experience of delivering documents according to client’s processes or we can follow our own ICH-compliant templates and rigorous document standards.
Our internal review process, which includes a peer review from senior team members and approval from our House Editor, is an essential part in developing high-quality, polished documents.
A formal quality control (QC) review is a stand-alone service recommended for regulatory documents. It involves a comprehensive check of the document against source documents and includes a 100% data check, with unverified information flagged up for consideration.
Our team has experience using a range of software but generally uses the industry-standard Microsoft Office suite and Adobe Acrobat.
Once the final MS Word version of a document has been approved by the client, we convert it to a PDF, including transfer of internal cross-linking and inclusion of appendices and attachments, as appropriate. 

This is an SOP-mandated process that includes a comprehensive check of all cross-links and formats.
The Niche writing process means that you can engage our delivery team at any point in document production. Any of your documents can be entered into our delivery platform, including scientific, editorial and quality review, ensuring that they are regulatory agency ready and meet all best practice expectations.

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