Are your documents ready for submission to major global agencies?

Your drug development program has overcome many challenges and required a substantial investment to get to this point. Now your submission documents require regulatory writing expertise across the full drug development lifecycle. Regulatory submissions from early stage INDs, NDAs, and MAAs require CMC, nonclinical and clinical expertise. Most importantly, your submission programs require the coordinated technology-enabled expertise that Synchrogenix Regulatory Writing offers.

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

Our writers have authored over 200 CMC, 350 nonclinical, and nearly 5,000 clinical documents for sponsors over the past 5 years.

“Your last comments and amendments are very valuable and virtually all of them have been implemented. Your team really did a great job in helping us to get the modules ready for submission. They look very clean and consistent now.” – Director, In Vivo Pharmacology, Toxicology & DMPK at a biopharmaceutical company in the EU

Regulatory writing to expedite your submissions

Our highly qualified team of writers include PhDs, MDs, PharmDs, scientists, and nurses with backgrounds across all functional areas
(Document Quality, CMC, Nonclinical, Clinical, and Regulatory).  Industry best-in-class SOPs drive quality while dedicated QC functions and integrated writing teams reduce reviewer comments and speed time to completion.

As key opinion leaders, Synchrogenix’s medical and regulatory writers speak regularly at major industry events such as DIA Annual and AMWA’s Medical Writing and Communication Conference.

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Proven track record of success in regulatory process and medical writing

We author CMC, nonclinical and clinical documents required throughout the full drug development lifecycle, including:
• Investigator brochures
• Clinical study protocols
• Clinical study reports
• Briefing documents
• All CTD Module 1, 2, 3, 4, 5 components
• Pediatric study plans/pediatric investigational plans
• Patient Narratives and Safety Reporting
• Annual Reports/DSURs/PBRERs

Our writers have authored over 200 CMC, 350 nonclinical, and nearly 5,000 clinical documents for sponsors over the past 5 years.

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Medical Device Clinical and Performance Evaluations

Since the introduction of MEDDEV 2.7/1 Rev 4, EU Medical Device Regulation (MDR) 2017/745, and In Vitro Diagnostic Regulation (IVDR) 2017/746, clinical and performance evaluations have been scrutinized by the notified bodies to ensure compliance with these regulations. Manufacturers have noticed that the bar has been raised for author qualifications, equivalence, literature reviews, clinical data, frequency of reports, and post-market clinical follow-up.

Our experts will work with you to ensure that you are prepared to meet the new regulations. Our medical device team consists of the following:

  • Experienced experts who have performed gap analysis, written, reviewed, and amended hundreds of clinical evaluation reports spanning all classes of device
  • Qualified medical writers, physicians, PhDs, nurses, and librarians
  • Skilled staff to perform methodologically sound literature reviews to support your clinical data
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Synchrogenix eCTD Authoring Template Suite

We’ve paired our technical experts with our team of qualified professionals in regulatory process and regulatory writing to create a comprehensive eCTD authoring template suite based on thirty plus years of experience planning, writing, editing, and publishing hundreds of global submissions.

The numerous template features simplify document creation and review and establish a standard approach to document development across different disciplines to ensure efficiencies between writing and regulatory operations teams.

  • Instructional text with current agency guidance maintained by regulatory experts
  • Specialized toolbar containing standardized shortcuts and symbols
  • Access to expert advice and technical support at all steps along the way

With toolbar features such as automatic formatting and easy table creation/conversion, our users are spending upwards of around 50% less time on document formatting.

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Synchrogenix Writer

Power your safety reporting by applying our experts and technology-enabled service delivery.

Reduce time to completion of large narrative projects while providing consistency.

  • Our experts engage Synchrogenix Writer’s narrative builder features to efficiently manage thousands of narratives to full completion, including review, in a fraction of the time
  • Templates can be developed/tested with pre-Database Lock data with no additional work required using post-Database Lock data
  • Gain speed, quality, and consistency across your narrative set
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Regulatory Writer Acceleration Residency (RWAR)

RWAR is a unique opportunity for those interested in becoming a regulatory writer. Learn from a team with a proven track record of success in various disciplines of regulatory writing.

During the residency, colleagues will embark on a two-year curriculum, which will teach the skills needed to lead regulatory writing projects while increasing exposure to documents that drive drug development. As a services organization, Certara Synchrogenix’s program offers the opportunity to develop skills necessary to work directly with our sponsors within the initial year of employment. Opportunities exist in the clinical, nonclinical, and pharmacovigilance disciplines.

The ideal candidates (hiring into this program every six months) will have the opportunity to participate in a mentor-driven training program that accelerates the transition to leading the writing efforts for regulatory documents.

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Ann Benesh, MPH Senior Director, Clinical Regulatory Writing

Ann has over 20 years of experience in medical writing.  Before joining Certara in 2013, she was a senior medical writer at Amgen for over 7 years and previous to that, a medical writer at 3M Pharmaceuticals.

Maria Lopez Director, Nonclinical/CMC Regulatory Writing

Maria has been at Certara for over 23 years, starting out in regulatory writing and quality assurance and advancing to her current role where she heads up the nonclinical/CMC regulatory writing team.

Dawn Guyer Director of Document Quality, Synchrogenix

Dawn has been at Certara for over 13 years. With both regulatory writing and editing experience, she is an experienced submission leader, company trainer, technical editor, project leader, and writer. She leads the Document Quality team, which includes our Technical Editing and QC team.

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