About Us

Synchrogenix partners with pharmaceutical and biotech companies to develop submission documents for global regulatory agencies.

Since 1986, our core competency at Synchrogenix has been regulatory writing for the pharmaceutical and biotech industry. Focusing on this crucial aspect of the drug development process has allowed us to hone our unique methodology and build a team of regulatory writers who are experts and thought leaders in the field.

Rather than vertically specializing in a functional area, as a CRO, CMO, or contract lab might, Synchrogenix horizontally bridges all functional areas within drug development. Our strength is integrating with key stakeholders to create submission documents that are comprehensive, concise, and clear, as well as consistent within and across the entire submission. Synchrogenix breaks through silos, uniting many single elements into one story…your story.

Synchrogenix is a leader in the regulatory writing field with a singular focus of authoring and editing regulatory documentation. We know that we are only as good as the documents that we produce. Therefore we are dedicated to the following ideals:

  • Nurturing our writers and editors to increase their knowledge of drug and biological development, and to ensure they are comfortably challenged in their careers.
  • Remaining immersed in global pharmaceutical, biotech, device, and diagnostics regulatory documentation requirements, to understand and anticipate our clients’ needs.
  • Ensuring that we utilize technologies and safety systems that offer the level of sophistication that is vital to our clients.

By merging our cross-functional expertise with our writing experience, we deliver documents that not only support clients’ strategic messaging, but also enhance their marketability. We provide many of the benefits of in-house writers—including the experience and perspective of industry insiders—without increased overhead or struggles with fluctuating workloads.

Read more about Our Team and our Latest Perspectives From Our Experts.