Assure and accelerate a successful regulatory submission
Partner with our team of expert regulatory operations specialists and publish with our proven eCTD software
Electronic Common Technical Document (eCTD) is the standard format for regulatory submission to many worldwide health authorities. eCTD format is required for submissions ranging from investigational applications to marketing authorizations, and all lifecycle management documentation in between (such as amendments, supplements, and annual reports). The International Council for Harmonisation (ICH) introduced eCTD formatting requirements for health authorities including: FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER); EMA, MHRA, Swiss Medic, TGA, and Health Canada.
eCTD publishing can be complicated and costly, especially as regulatory agencies require even more submission-types in electronic formats. These include eCTD submissions in support of New Drug Applications (NDAs), Marketing Authorisation Applications (MAAs), New Drug Submissions (NDS), Investigational New Drug (IND) applications, and many more. In addition, maintaining compliance will be increasingly difficult as regulatory requirements and mandates change across markets.
Certara Synchrogenix provides the services to help avoid common issues that can lead to submission rejections by partnering with a team of experts who have a proven track record of success in regulatory submissions, compliance, and eCTD management software.
Certara Synchrogenix ensures efficient, timely submissions through our GlobalSubmit eCTD software and our experienced team of regulatory operations and eCTD publishing specialists.
Whether you are seeking a full-fledged regulatory operations consultancy to act as your department, a provider for occasional overflow support, or licensable eCTD software solutions, Certara Synchrogenix offers partnership models customized to meet any and all of your needs.
Anticipating challenges helps accelerate submissions and mitigate risks of costly delays
A provider with deep knowledge in regulatory submission process enables fast response 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
Trust the experts
With decades of submission experience, our experts maintain a deep regulatory knowledge that enables immediate response to every new mandate and requirement change.
As key thought leaders, our regulatory operations specialists frequently speak at major industry events, partner with various regulatory organizations and share our knowledge through blogs and webinars.
Check out our latest regulatory operations blog posts:
GlobalSubmit eCTD Submissions Management Software
Our regulatory operations specialists consult with your team, utilizing easy-to-use eCTD software needed 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
GlobalSubmit eCTD Submissions Management Software is available as a solution or through our regulatory support services.
Supporting regulatory submissions to major global agencies
- Marketing application submissions: NDA (New Drug Application), ANDA (Abbreviated New Drug Application, sNDA (Supplemental New Drug Application), BLA (Biologics License Application, MAA (Marketing Authorisation Applications), NDS (New Drug Submission)
- 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. Our team also provides US Agent support to sponsors who need an authorized U.S. Agent to interact with the FDA on their behalf.
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.
Maryanne is an accomplished, results-driven regulatory affairs professional specializing in eCTD submissions, FDA interactions, and project management. With 20+ years of experience, she 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.
Maryanne is an accomplished, results-driven regulatory affairs professional specializing in eCTD submissions, FDA interactions, and project management. With 20+ years of experience, she has a proven track record of successful regulatory submissions to a variety of regulatory authorities.
