Customized regulatory submission support and eCTD software that assures and accelerates success
Regulatory publishing services and submissions management provided by regulatory operations specialistsSubmission 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 with a proven track record of success in regulatory submissions, compliance, and eCTD submissions management software.
Certara ensures efficient, timely submissions through our GlobalSubmit eCTD software and Synchrogenix team of regulatory operations and eCTD publishing specialists.
Custom partnership models are available that add capabilities and capacity to your staff that range from eCTD software solutions for your submission management to full-fledged support as your regulatory operations department.
We collaborate closely with our partners to achieve regulatory milestones on time, if not sooner.
Testimonials:
“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
“For a small team that has limited time to compile and double check a submission, GlobalSubmit is a really good platform because it is all integrated, including CROSSCHECK and VALIDATE. So, you know when you generate the submission that it is compliant, and you don’t need another tool for validation.”
– Jessica Pung, MS, RAC, Associate Director of Regulatory Operations | Prelude Therapeutics
“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
Deep knowledge in regulatory process enables fast responses to changes in regulatory requirements and mandates.
- Achieve submission deadlines on or ahead of schedule
- Maximize re-use of content and minimize additional costs for submissions to additional global agencies.
- Mitigate the risk of errors and costly delays.
- Avoid rework by generating compliant, validated submissions the first time.
- Internally review and approve submissions easily and efficiently.
- Know where your submission is in the publishing process at all times.
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.
GlobalSubmit eCTD Submissions Management Software
Provide your regulatory operations team the eCTD software they need to efficiently publish, validate, and review regulatory submissions.
- GlobalSubmit PUBLISH — Publish regulatory compliant PDF submissions for various health authorities
- GlobalSubmit VALIDATE — Assess the technical validity of your eCTD submission and eliminate the risk of technical rejection
- GlobalSubmit WebReview — Facilitate the timely review of your eCTD submissions across various stakeholders
Supporting regulatory submissions to major global agencies
- Marketing application submissions (NDA/ANDA/sNDA/BLA/MAA/NDS)
- Investigational and master file submissions (IND/DMF/ASMF)
- Lifecycle maintenance submissions
- Master file submissions
- U.S. Agent services
- Electronic transmission
- Regulatory consulting
We support global submissions to FDA, EMA, MHRA, Swiss Medic, TGA, and Health Canada regulatory authorities.
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.