Synchrogenix, a Certara company

Synchrogenix provides regulatory and communications strategy, science, and solutions 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.REGULATORY STRATEGY- Strategic cross-functional guidance and comprehensive implementation- Submission and Program Leadership- Strategic messaging alignment, overall Vendor strategy and management, agency communications - Modules 1-5 of the Common Technical Document (CTD) / PMA, 510k - Regulatory Operations ServicesREGULATORY and MEDICAL WRITINGBy merging our cross-functional expertise with our writing and operations experience, we deliver documents that not only support clients’ strategic messaging, but also enhance their marketability. We provide many of the benefits of an in-house team—including the experience and perspective of industry insiders—without increased overhead or struggles with fluctuating workloads.Synchrogenix provides clients with objective, professional document review services. Our rigorous quality-control process includes checks of data, formatting, spelling, grammar, and clarity. Our team includes industry experts, medical doctors, and clinicians who provide our clients with objective content review.TECHNOLOGY-ENABLED SERVICES- GlobalSubmit™ Regulatory operations technology - ClinGenuity™ Artificial intelligence technology platform TRANSPARENCY and DISCLOSUREOur disclosure team consults with our clients to educate cross-functional teams as to the requirements for and compliance to FDAAA, FDAMA, and EMA's policies 43 and 70. We develop a roadmap for compliance for our domain experts to fulfill in tandem with client stakeholders. - Global Trial and Results Registries - Redaction and Dataset De-Identification- Plain Language Summaries