Medical Writing

Our medical writers prepare the scientific documents you need for regulatory submissions, from protocols to clinical study reports to CTD modules.

Overview

Regulatory documents need to be scientifically accurate, clearly written, and formatted exactly right. Our writers have therapeutic area expertise and know the regulatory guidelines inside out. We write protocols that pass ethics committee review, CSRs that follow ICH E3 structure, and submission documents that help reviewers understand your data.

What We Do

Clinical trial protocols with detailed statistical sections and endpoint definitions

Clinical study reports following ICH E3 guidelines with integrated summaries

Investigator brochures that synthesize preclinical and clinical safety data

Module 2 summaries for CTD submissions including clinical overview and summary

Briefing documents for regulatory meetings and responses to information requests

Why Work With Us

Our writers have PhDs and medical degrees with 10+ years in clinical research

We've written successful IND, NDA, and MAA submissions across multiple therapeutic areas

Quality review process catches errors before documents go to regulators

Related Services

Regulatory Services

CDSCO, USFDA, and global submissions

Bio Statistical Services

Study design and statistical analysis

Clinical Development Services

Phase I-IV trial management

Pharmacovigilance

Safety monitoring and adverse event reporting

Ready to Get Started?

Let's discuss how we can support your medical writing needs.