Assure submission success
Submission publishing can be prohibitive and costly with regulatory agencies requiring ever more submission types in electronic formats. Changing regulatory requirements and mandates across markets makes maintaining compliance increasingly difficult.
Avoid common issues that can lead to submission delays and rejections by partnering with a team of experts in regulatory submission and compliance with a proven track record of success.
Certara’s Synchrogenix Regulatory Operations and eCTD Publishing specialists provide unrivaled expertise, assured compliance, and advanced technology to ensure the successful execution of regulatory submissions. Custom partnership models are available that add capabilities and capacity to your staff including acting as your full-fledged regulatory operations department.
We collaborate closely with our partners to achieve regulatory milestones on time, if not sooner.
“Working with Synchrogenix was the next best thing to having a fully staffed and seasoned RegOps team on site.” – Vice President of Regulatory Affairs | Gritstone Oncology
“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
Anticipating challenges helps accelerate submissions and mitigates risks of costly delays Contact us
Deep knowledge in regulatory process enables fast responses to changes in regulatory requirements and mandates.
- Proven track record for successful eCTD delivery for every therapeutics area
- Flexibility to meet your changing priorities and timelines
- Simplified submission review
- Proactive management of project timelines and deliverables
As key opinion leaders, Synchrogenix’s regulatory operations and eCTD publishing specialists speak regularly at major industry events such as DIA Annual, DIA RSIDM, and RAPS Regulatory Convergence.
Supporting regulatory submissions to major global agencies Download brochure
- Investigational and marketing application submissions (IND/NDA/ANDA/sNDA/BLA/MAA/DMF/ASMF/NDS)
- Lifecycle maintenance submissions
- Master file submissions
- Dossier management
- U.S. Agent services
- Electronic transmission
- Regulatory consulting
GlobalSubmit eCTD Submissions Management Software Get a demo
- GlobalSubmit PUBLISH for more efficient document and submission level publishing and QC
- GlobalSubmit VALIDATE helps to ensure the technical validity of your submissions for the region to which you are submitting
- GlobalSubmit WebReview for streamlined submission review, anytime and anywhere
- GlobalSubmit CROSSCHECK to efficiently QC your bookmarks and hyperlinks to not only make sure they are technically sound, but also directing reviewers to the correct locations in your submissions
Evan is an accomplished, results-driven regulatory affairs professional specializing in eCTD submissions, FDA interactions, and project management. With 15+ years of experience, he has a proven track record of successful regulatory submissions to a variety of regulatory authorities.
Rob has over 25 years of experience in regulatory submissions. He has involvement in the production of electronic regulatory submissions to numerous health agencies, at all roles and leadership levels. Rob has been with Certara’s Synchrogenix division for 5 years where he heads up the regulatory operations team.
Evan is an accomplished, results-driven regulatory affairs professional specializing in eCTD submissions, FDA interactions, and project management. With 15+ years of experience, he has a proven track record of successful regulatory submissions to a variety of regulatory authorities.
Rob has over 25 years of experience in regulatory submissions. He has involvement in the production of electronic regulatory submissions to numerous health agencies, at all roles and leadership levels. Rob has been with Certara’s Synchrogenix division for 5 years where he heads up the regulatory operations team.
