About Us

Synchrogenix provides regulatory and communications strategy, science, and services to life science companies worldwide. Our regulatory expertise and innovative technology bridges the full regulatory continuum to propel treatments to the market by meeting the needs of all stakeholders and improving public health outcomes. With eighteen locations across three continents, Synchrogenix meets the needs of sponsors around the clock and around the globe.

From global submission strategy and regulatory operations leadership, to regulatory and medical writing, to transparency and disclosure compliance, we propel products from model to patient access.

Regulatory Strategy, Sciences and Services

Our team of medical and regulatory writers includes strategy experts, MDs, PhDs, PharmDs, nurses, clinicians, and Six Sigma Black Belts. These cross-functional capabilities merge writing skills with operations experience to deliver documents that support strategic messaging and marketability. We also complete objective, professional document reviews using a rigorous quality control process, only delivering results of the highest quality.

Our extensive team of subject matter experts offer regulatory strategy services, including program and submission leadership, consulting, and agency communication.  By closely linking the authoring phase and with our comprehensive GlobalSubmit™ regulatory operations tools and services, we create a direct hand-off that shortens timelines and reduces the risk involved in filing.

Synchrogenix also provides a range of transparency and disclosure services to address the ever-evolving compliance landscape. Our Complete Compliance™ support includes: global trial and results registries, plain language summaries, redaction, and dataset de-identification. Our exclusive ClinGenuity™ Artificial Intelligence technology automates these processes, increasing both speed and accuracy.

Synchrogenix proudly leads the transformation of research and development through our end-to-end regulatory expertise and technology-enabled solutions.

Visit Synchrogenix.com for more on information.