Regulatory documents are a distillation of the time, effort and money you have invested to obtain your data.
A poorly written and presented document fails to do justice to your work and can result in unnecessary questions and confusion.
And it’s not only regulators who are influenced by the quality of your regulatory documentation; investors, partners and licensees will perform rigorous reviews before they enter into a deal. The authoring of regulatory documentation is a skilled job demanding accuracy and creativity in order to identify, extract and clearly present the required level of detail appropriate to fulfill the objective of the document concerned.
Boyds leverage many years of regulatory and medical authoring experience together with an in-depth understanding of the required content of each regulatory document based on the stage of development and type of product.
We can simply review, or take the lead authoring role, working cross-functionally with your team members as required. Either way, we can help.
“Working with you in the preparation of high quality regulatory medical writing and documentation to support your development activities.”
- Investigational Medicinal Product Dossiers (IMPD)
- Clinical Expert Overviews and Summaries
- Quality Overall Summaries
- CTD Module 3
- Scientific Advice Briefing Books
- Orphan Drug Applications
- Paediatric Investigational Plans
- Environmental Risk Assessments
- Investigator’s Brochures
- Product Specification Files