synchrogenix provides regulatory and communications ......• public disclosure compliance program...
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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.
2 www.synchrogenix.com
Regulatory Intelligence, Policy & StrategySynchrogenix’s Office of Regulatory Intelligence, Policy and Strategy is comprised of proactive policy drivers focused on efficient planning who provide real-time regulatory insights to guide sponsors through the global regulatory maze by making connections with new precedents and trends to influence outcomes and maximize success.
Regulatory CommunicationsQuality information handling is vital throughout a drug’s lifecycle. Synchrogenix provides distinct market offerings that advance and protect ownership, yet support collaboration through customer engagement and transparency.
Regulatory OperationsSynchrogenix ensures efficient, timely submissions through software and services solutions that break down barriers between strategy, dossier development and global transmissions. Through experience, expertise, and industry insight, Synchrogenix quickly responds to changes in global regulatory requirements and mandates, thus avoiding common issues that can lead to rejections.
Technology & InnovationSynchrogenix delivers interoperable and innovative technologies that support our services and differentiate ourselves in the market. Additionally, Synchrogenix provides strategy and delivery capabilities to implement emerging technology solutions both internally and externally.
Global Stakeholder CommunicationsSynchrogenix provides expertise and relevant communications to global audiences through services and innovative technology. Our offerings support our clients’ regulatory compliance, while reducing risk and enhancing potential for market success. These offerings include, but are not limited to: regulatory writing, medical communications, safety/pharmacovigilance, patient engagement, and transparency and disclosure.
Synchrogenix - Providing regulatory and communications strategy, science, and solutions.
Comprehensive Regulatory & Communications Strategies, Science & Solutions
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Atlanta, GACambridge, MACincinnati, OHDaresbury, UKGaithersburg, MDLondon, UKMalvern, PAManila, PHIMontreal, QC
Nashville, TNOrlando, FLParsippany, NJPhiladelphia, PARaleigh, NCSan Diego, CAThousand Oaks, CAWilmington, DE
• Program management
• Global planning
• Due diligence
• Strategic planning and readiness preparation
• Regulatory writing and medical communications
• Nonclinical; clinical; chemistry, manufacturing and controls; safety/pharmacovigilance
• Technical editing
• QC/QA
• Niche capability to address clinical pharmacology and Model-Informed Drug Development with scientific writing
• Study level and global filing documents
• Submission management
• Submission compilation
• Document level and submission level publishing
• Document management and maintenance
• Regulatory correspondence
• Clinical trial postings
• Tech-enabled document redaction and anonymization
• Public disclosure compliance program
• Plain language summaries
Consulting Communications Operations Transparency & Disclosure
Synchrogenix - Providing regulatory and communications strategy, science, and solutions.
Our Expertise & Services
Our Global Footprint Our Value
SupportingSponsorsFor Over
32years
SUPPORTto align withGLOBAL TEAMS
Repeatbusiness &expansion85
over%
INDUSTRY LEADING A.I.-enabled authoring & redaction technology
Largest regulatory and medical writing group
Touched over 95% of eCTD submissions ever created95
over%
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Synchrogenix - Regulatory and Communications Strategy, Science, and Solutions
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.
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