Services
Medical writing leadership solutions customized for your clinical development program
What we write
New drug application (NDA) / marketing authorisation application (MAA) / biologics license application (BLA):
Module 2.5 (clinical overview)
Module 2.7.4 (summary of clinical safety)
Module 2.7.3 (summary of clinical efficacy)
Integrated summary of safety (ISS)
Integrated summary of effectiveness (ISE)
Clinical study reports
Clinical study protocols / amendments
Briefing documents
Responses to regulatory information requests
Investigator’s brochures / updates
Special designation applications
Development safety update reports
Narratives
Something else? Please contact to discuss.
How we do It
Review existing program documents, including regulatory history
Assess document development pain points and implement real-time solutions
Lead the end-to-end authoring/reviewing process:
Develop documents shells and/or full first drafts
Oversee document progress, incorporating revisions and regular quality checks to build internal consistency
Generate timelines
Facilitate kickoff and adjudication meetings
Route documents for review
Primary publishing
Why partner with us
Our team is dedicated to yours – We offer packages that can be customized to meet your team’s medical writing needs:
Fractional Medical Writing Leadership Package:
The fractional medical writing leadership package offers a cost-effective, flexible, and experience-rich alternative to hiring in-house medical writers. We integrate with your internal team to stay in sync with current thinking and to help drive end-to-end clinical/regulatory document planning and execution. This package enables the agility to pivot quickly based on sponsor priorities and timelines and grants premium status in our portfolio, enabling us to accommodate urgent requests and intermittent peaks in project activity that may exceed predetermined resource allocation.
Prioritized Deliverable Package:
The prioritized deliverable package allows you to reserve our experienced team for specific upcoming deliverables on a per-project basis. This package includes end-to-end medical writing leadership for individual documents with upfront cost transparency.
On-demand Medical Writing Services:
On-demand medical writing services grant you access to our nimble, collaborative team without an ongoing commitment. Availability to fulfill on-demand requests is determined at the time of inquiry, typically within 4 weeks of project kickoff.