Synchrogenix is committed to a continuum of innovation. Through technology-enabled solutions, we optimize our contributions from early phase development through lifecycle management. We effectively bridge content generation to knowledge communication with our Artificial Intelligence and Regulatory platforms to reach various stakeholders.
Synchrogenix provides regulatory strategy, science, and services to pharmaceutical, device, diagnostics, and tobacco companies worldwide. With seventeen 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.
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.