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 worldwide 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 worldwide through customized regulatory solutions, including strategy, communications, operations and technology.

Visit us at CBI's Clinical Data Disclosure, Transparency & Dissemination Conference
January 22-24 | Coral Gables, FL

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Achieving Regulatory Success

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

Customized Regulatory Solutions Backed by A Proven Record of Success

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Increase your product's chance of expedited approval and greater patient access with global program development guidance from seasoned experts. More.

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Communicate with confidence beside a strategic partner who has the knowledgeable professionals and depth of expertise your scientific investment deserves. More.

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Streamline your electronic submissions and file on time, if not sooner with dedicated publishing teams who are scalable and provide visibility throughout the entire process. More.

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Advance your drug approvals utilizing the industry’s leading-edge technologies for writing and content reuse, submissions management, and transparency and disclosure. More.