Best-in-class Writing

At Synchrogenix, writing is our core competency. All of our writers are experienced regulatory writing experts with a thorough knowledge of regulatory documents and the drug development process.

All Synchrogenix employees are trained in industry best practices and our SOPs, including our rigorous quality control process, which ensures an objective review of each draft and final document before delivery.

Synchrogenix's cohesive writing group can maintain strategic messaging across functional areas, ensuring a document that reviewers will find complete, consistent, and readable. By making documents clear and accessible the first time, Synchrogenix reduces reviewers' questions and concerns, expediting movement through regulatory processes.

Our experience and areas of expertise encompass Modules 1-5, including development plans, investigator's brochures, protocols and CSRs, summary documents, and briefing packages.