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As a specialist service provider in this area, we continue to provide leadership, plus content writing and guidance on report structure, to existing and new clients wherever needed, and have a full and broad understanding of all necessary requirements for all types of safety reports.
The diagram below sets out how our team can support you in the preparation of safety documents for all stages of your clinical development programme:
Pharmacovigilance medical writing across the drug development process
Please call us for a confidential discussion of your project writing needs.
For the clinical development phase:
In preparation for marketing authorisation:
For the post-marketing phase:
Pharmacovigilance medical writing plays a crucial role at every stage of the drug development process.
From clinical development through to the mandatory submission reports required prior to obtaining regulatory approval for marketing, pharmacovigilance medical writing is a necessary element at every stage. This requires the presence of specialised writers for successful navigation through the various sets of technical requirements.
The clinical development phase of any drug requires annual DSURs in the EU and IND Annual Reports or DSURs in the US, which are used to report on the safety of participants in clinical trials.
When submissions are made for marketing authorisation, reports analysing safety data make up a significant proportion of the submitted documentation.
After marketing authorisation is granted, pharmacovigilance medical writing specialists are needed to ensure the quality of documents such as PSUR/PBRERs, RMPs and ad-hoc safety reviews.
And of course, RMPs and Benefit-Risk Evaluation Reports continue to be updated throughout a product's life cycle, meaning the need for pharmacovigilance medical writing expertise remains constant.