Boyds’ highly experienced Regulatory and Medical Writing team have expertise across a wide range of therapeutic areas and clinical and regulatory document types and can offer a flexible approach to suit your needs.
Our medical writing experts are highly skilled at analysing, interpreting, and presenting complex and diverse data to produce well-written, scientifically accurate, and polished documents that meet all regulatory requirements. Our Medical Writers have many years of authoring experience across documents spanning the drug development process, from protocols and Investigator’s Brochures through to Clinical Study Reports and Common Technical Document (CTD) modules. This makes us very well placed to work on submission packages, where an understanding of the full picture and maintaining consistency across documents is crucial.
We are well‑versed in working with different team structures and can be flexible in our approach to work in a way that suits your needs. If needed, we can lead all aspects of your document development, from project start-up to managing the review process. For clients who do not have well‑developed processes, we can offer advice on best practices and have a suite of document templates that adhere to the relevant regulatory guidelines. We are equally at home working with large interdisciplinary teams and following clients’ processes, guidelines, and templates.
“Collaborating with your team in the preparation of the highest quality clinical and regulatory documents to support your development activities.”
- Investigator’s Brochures (IBs) and IB updates
- Clinical study protocols and protocol amendments
- Clinical Study Reports (CSRs)
- Patient safety narratives
- Informed Consent Forms (ICFs) and Subject/Patient Information Sheets
- Plain language summaries
- Common Technical Document (CTD) modules
- Briefing books/Scientific advice/Innovation Office interaction documents
- Regulatory responses
- PRIority MEdicines (PRIME) scheme applications and Designation requests (Fast Track/Breakthrough Therapy/Regenerative Medicine Advanced Therapy/Rare Pediatric Disease)
- Orphan drug designation requests
- Paediatric Investigation Plans (PIPs)/Initial Pediatric Study Plans (iPSPs)
- Investigational Medicinal Product Dossiers (IMPDs)
- Scientific publications (e.g., abstracts and manuscripts)
- Standalone quality control and editorial support including document formatting
- Uploading study results to clinical trial registries
Get in touch
If you would like to talk to a member of our team about a specific project or area of expertise, then please complete this form and we will get in touch.