SCIENTIFIC & MEDICAL WRITING.
Regulatory Writing Services
Navigating complex regulatory landscapes with confidence.
The path to market approval is paved with documentation. We help CROs, biotechs, pharmaceutical companies, and clinical teams deliver submission-ready clinical documents faster and with fewer revisions.
What we can help you with
- Clinical Study Protocols (CSPs)
- Clinical Study Reports (CSRs)
How we help you
- Compliance: ICH E3 / E6 aligned
- EMA/FDA Submission Readiness
- QC-checked documents
- Consistent project narrative across your regulatory documents.
- Timeliness: On-time delivery aligned with study milestones
Our team on your project
Our scientific and medical writing team includes 9 experienced writers and editors, all of whom have a solid research trajectory, mostly in biomedical and clinical research.
For every project, we assign a team of two experienced professionals, with distinct roles:
- An experienced medical writer to lead content development
- A project manager to oversee deadlines and to double-check the precision of every deliverable
Our workflow
We have developed a modular pipeline that adapts to your project according to how much support you need.
- Opening meeting: We schedule an exploratory call/meeting with you to discuss the project and your support needs.
- Data transfer: You share with us all information required.
- First draft and questions + your feedback and answers: We build a first draft, pose questions for you to resolve, and you send us your answers and feedback.
- Full draft + your feedback: We develop a full draft based on your initial feedback and answers, and you send us your final feedback.
- Reviewing and Quality Control: We review and incorporate your feedback and perform a Quality Control on the final document.