Two gene therapy companies were in need of regulatory writing support for pivotal clinical study reports (CSRs). They engaged with Certara’s Cell & Gene Therapy practice because of its proven regulatory and medical writing expertise across therapeutic areas.
One developer needed several CSRs written, but had poor source materials. The company relied on Synchrogenix, Certara’s Regulatory Science Division for regulatory writing to develop CSRs that presented a cohesive, compelling, and concise story around their drug, which had shown amazing results.
Another developer engaged Synchrogenix to drive the CSR writing process fully and to completion. Synchrogenix’s experts provided a convincing framing of the key data and conclusions in support of regulatory requirements.