Welcome to eCTD Submit
As highly experienced regulatory, publishing and eCTD experts, we pride ourselves on speed, accuracy, and our ability to adapt quickly to changing business situations—such as shortened lead-times or sudden urgent submissions.
Whether you’re facing tight timelines, limited budgets, or some other challenge, our seasoned team will build a solution guaranteed to meet your specific needs.
Why eCTD Submit?
While working for pharmaceutical companies each of our founders grew frustrated with the eCTD publishing service providers with whom we worked.
Exorbitant fees for slow turnarounds, lack of communication, and inflexibility made us think, ‘Surely, it should be better than this.’ Hearing our industry peers echo this dissatisfaction motivated us to set up eCTD Submit.
Now, over 10 years later, our guiding principle remains: give customers the swift, effective, personalized service they deserve.
Whatever the challenge, we’ll ensure you meet your goals
We provide the same outstanding quality of service across all electronic submissions, be it an IND submission, a BLA, conversion to eCTD format or simply the maintenance of an existing application.
Services we provide:
- eCTD submission outsourcing
- eCTD lifecycle management – We provide continued support for all future sequencers of your application.
- ESG for FDA & Health Canada – We securely transmit to FDA or Health Canada using the authorized portal.
- Conversion of DMFs to eCTD
- Regulatory writing and review – Our medical writers and MDs can author your regulatory documentation.
- Regulatory affairs and operations – We provide regulatory management and operations support as a matter of course.
- Staff augmentation – If you are short-handed we can provide additional regulatory support at most levels. We supply ad-hoc staff members who are fully trained and ready to increase your deliverables. They can work with you ‘on-site’ or remotely.
- Regulatory strategy consulting
- Document publishing – We prepare documents for publishing by optimizing templates, hyperlinking, bookmarking, formatting and converting files to the necessary standards.
- Document submission and QC
- Labeling advertising and promotional materials – We provide SPL services, drug registration and listings, and 2253 submissions.
- Legacy paper management and conversion to eCTD – We deliver legacy paper submission publishing, NeeS and conversions to eCTD, including scanning services, record management, site closures and M&A document transfers.
- Business process analysis, consulting and optimization
- EU submissions
Your international partner
Our global presence and international network of publishing experts means we’re perfectly placed to meet your needs in the US, Canada, Europe and beyond.
Experts with years of experience
Alice Bexon
Co-founder and Chief Medical Officer
Alice is a 25-year+ veteran drug developer who trained as an MD in the UK then worked as an oncologist in France. She has worked for co-operative groups, CROs, global pharmaceutical companies and biotechs. Along with a wide-ranging knowledge of clinical development and medical marketing, Alice has extensive regulatory experience interacting with bodies such as the FDA and EMA.
Pete Minnick
Co-founder and Vice President of Regulatory Operations
With over 25 years of experience in regulatory operations, Pete has established himself as one of the top eCTD experts in the industry today. He has been involved with eCTD format since it’s inception and was even involved in one of the first pilot eCTD submissions with the FDA. Pete runs our publishing team with a deep understanding of regulatory and pharmaceutical industry standards. He has been involved in thousands of original filings, and hundreds of thousands of eCTD sequences submitted to every agency around the world.
Tim Reid
Co-founder and Head of Technology
Tim’s financial and risk management expertise was forged on Wall Street and the Paris Bourse, where he led software development teams focused on risk modeling and management. However, in eCTD Submit Tim returns to his origins in the life sciences—he began as a research scientist studying the underlying mechanisms of metastatic cancer in Japan, France, the Netherlands, and the UK. Now Tim brings his unique experience to bear ensuring good value and security for our clients.
Mike Yefimenko
Co-founder and Vice President of Regulatory Affairs
As an accomplished regulatory expert with a broad grasp of clinical, non-clinical and manufacturing requirements, Mike’s 20-year+ career in regulatory affairs encompasses major pharmaceutical companies, CROs, medical device manufacturers and combination product companies. In addition to his extensive regulatory knowledge, Mike has a long history of personal interactions with regulatory bodies such as the FDA, EMA, rapporteurs and notified bodies, including broad experience preparing for (and passing!) regulatory inspections.
Happy clients
“The biggest advantage of working with
eCTD Submit…they are a true integral
member of the development team…I
have complete confidence in them.”
Alex Zukiwski, Casi Pharmaceuticals
“Working with this team has
streamlined our entire process…
they’re an extended part of my team.”
Sean Russell, Primera Pharma Partners
eCTD Submit’s Navigator—it’s an amazing
tool. It gives you exactly what you need
…you can access the documents in a
meaningful and useful way.”
Alex Babayan, Allogene Therapeutics
“The eCTD Submit team turned around
the publishing in under 2 days, which
was really outstanding…”
Tory Lake, March Bio
eCTD Office™
At eCTD Submit we use eCTD Office™ – it’s one of the world’s leading software publishing packages. It’s an integrated eCTD/NeeS/VNeeS software product for the creation, validation and publishing of regulatory documentation for electronic submissions.
eCTD Office™
As the exclusive US representatives of this innovative software, we are able to offer you customer service in the form of:
- Full technical support.
- User training on an individual or group basis.
- Expert review and quality control to ensure your documents adhere to FDA submission guidelines.
- Creation of SOPs, validation and other technical documents needed to implement publishing software.
eCTD Navigator™
Our proprietary web-based eCTD Navigator™ allows our clients to retain control and visibility of their submissions with its unique draft, comments and status functionality. All of your submissions and files are securely available online for you to access anywhere, at any time.
Easy-to-use templates
Whatever submission you need to prepare, we have the necessary templates to help guide the writing process.
Our templates are simple and intuitive to use and ensure consistency across application documents. In addition, we can provide medical writing support throughout the entire project.
Get in touch
However you want to get in touch, we look forward to hearing from you.
Address:
eCTD Submit, 551 Valley Road #188
Upper Montclair, New Jersey 07043, USA
Email:
Call:
+1 973.396.4956
Human Resources
As new projects come up, we are always looking for new publishers. If you’d like to be considered for a position in a fast-paced, growing company please send your CV to hr@ectdsubmit.com.