Preparing and reviewing regulatory documents, including Clinical Study Reports (all phases), Clinical Study Protocols, Marketing Application Summary Documents including IND/NDA/BLA/MAA, Investigator Brochures, Briefing Packages, Development Safety Update Reports (DSURs), and Patient/Event Narratives.
Regulatory affairs support during document development and experience in submissions management.
Patient and event narratives are important components of CSRs, and producing them in a timely manner with high quality is critical to the success of the project. We help express narratives clearly and succinctly while synthesizing information from various sources and experts, all with the experience to stay under budget.
Formatting & Submission Readiness
Formatting, pre-publication, and full publishing services for all document types.
Robust Quality Control processes, including verification of all data against source documents, internal consistency and completeness checks, compliance with ICH/regulatory agency guidances, and verification against style guide.