Get it right the first time

Preparing a regulatory submission for global regulatory approval requires significant expertise, effort, and attention to detail. A large, diverse team, numerous tools, planning, and processes must work together in harmony for a successful outcome. Complexity, risk, time, and costs typify every submission. Without careful execution and the ability to navigate unexpected challenges, your submission may face costly delays.

Certara Regulatory Science, also known as Synchrogenix, assures and accelerates the approval of and access to medical innovations through a unique combination of customized regulatory strategy, document authoring, medical communications and publications, and operations solutions. Our proven record of success is built on our expertise, and an unrivaled commitment to quality and compliance combined with the use of advanced technologies to enhance speed and efficiency.

Here is what our partners say:

I consider Synchrogenix to be the gold standard for our vendors because of the excellent service they provide.” – Vice President, Regulatory Affairs | Banner Life Sciences

You may have seen the announcement that the FDA has accepted our NDA filing. I just want to say, thank you to each and everyone else at Synchrogenix and Certara who helped us get to this point. There’s more to come, but this is a big deal for us and soon for patients. We couldn’t have done it without you.” – Vice President, Program Management at a biopharmaceutical company

 

How we help our clients

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Regulatory Writing

Synchrogenix regulatory writers offer deep technical and therapeutic expertise across all submission document types to create and deliver submission documents on time, every time.
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Scientific and Medical Communications and Publications

When it comes to scientific medical writings, our specialists provide strategic expertise and execution to deliver quality publications from start to decision.
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Safety and Pharmacovigilance

Safety-related document authoring support, including patient safety narratives, CTD documents (2.7.4, ISS), and more throughout the entire safety lifecycle for major global agencies.
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Regulatory Consulting and Regulatory Affairs

Proactively partner with a team that will evaluate your program and provide a tailored regulatory strategy while ensuring your program’s compliance with maximum efficiency.
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Regulatory Operations and eCTD Publishing

Streamline your electronic submissions and file on time with dedicated and scalable publishing teams who provide visibility throughout the entire process.
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Transparency and Disclosure

Enhance patient engagement, meet transparency and disclosure requirements, and maintain compliance with expertise and leading technology-enabled services.
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Regulatory Technology

Accelerate and advance your product approvals with technology solutions from regulatory experts that powers operational efficiencies.
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eCTD Submissions Software

The GlobalSubmit™ platform allows you to efficiently publish, validate and review electronic common technical document (eCTD) submissions. Eliminate risk and avoid unnecessary steps.
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Achieve regulatory milestones

We focus on regulatory strategy first, and then map an efficient and effective operational plan. By involving us as a strategic partner—as early as identification of a lead candidate through life cycle management.

We ask the right questions during front end meetings and working together, assess the right processes, tools, and resources to achieve all your goals.

Supporting you from R&D through life cycle management

An astonishing number of documents, communications, and presentations must be produced at every stage of development.

Our highly skilled and scalable team manages the transition from pre-clinical programs to clinical development, through submission and approval, to post marketing safety with rigorous and proven quality control processes.

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How can we help you?

Contact us today to discuss how we can help you achieve your regulatory milestones.

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