Synchrogenix

Certara Supported 90+ Percent of US FDA Novel New Drug Approvals for the Fourth Consecutive Year

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Achieving Regulatory Success

As Certara's Regulatory Science Division, Synchrogenix accelerates the regulatory submissions of medical innovations through customized regulatory solutions, including strategy, communications, operations and technology.

FDA Renews Licenses for Synchrogenix's GlobalSubmit Software to Review and Validate New Drug and Biologics Applications

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Achieving Regulatory Success

As Certara's Regulatory Science Division, Synchrogenix accelerates the regulatory submissions of medical innovations through customized regulatory solutions, including strategy, communications, operations and technology.

Visit Us at AMWA's Medical Writing & Communication Conference
November 6-9 | San Diego, CA

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Achieving Regulatory Success

As Certara's Regulatory Science Division, Synchrogenix accelerates the regulatory submissions of medical innovations through customized regulatory solutions, including strategy, communications, operations and technology.

GlobalSubmit WebReview is a Simple, Secure eCTD Viewer with Anytime, Anywhere Access

Try it at No Cost for 30 Days!
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Achieving Regulatory Success

As Certara's Regulatory Science Division, Synchrogenix accelerates the regulatory submissions of medical innovations through customized regulatory solutions, including strategy, communications, operations and technology.

 

Regulatory Intelligence, Policy & Strategy

Synchrogenix’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 Communications

Quality 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 Operations

Synchrogenix 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.

Global Stakeholder Communications

Synchrogenix 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.

Technology & Innovation

Synchrogenix 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.

Program management

Global planning

Due diligence

Strategic planning and readiness preparation

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Regulatory and medical writing

Medical communications and publications planning

Technical editing

Transparency & disclosure

Health Economics Outcomes Research (HEOR)

Study level and global filing documents

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Paper to electronic common technical document (eCTD) conversions

U.S. Agent services for non-U.S. sponsors

Submission and Publishing Services

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Regulatory Content Creation

eCTD Submissions Software

Authoring Templates

Transparency & Disclosure

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  • Everyone at Synchrogenix is very knowledgeable, professional and always eager to assist. Very trustworthy.

    Lisa, Regulatory Submissions Specialist

  • Excellent subject matter expertise, customer service, responsiveness, and flexibility. A pleasure to work with the entire team."

    George, Vice President, Regulatory Science

  • They were very helpful in getting us into eCTD for FDA submissions. Patient and willing to explain when we didn’t have a clue.

    Jane, Regulatory Affairs/Compliance Associate
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