Regulatory Document and Submission Publishing Services

Most life science companies need publishing experts.

Without dedicated in-house expertise, managing documents and submission publications can be overwhelming.

I’m worried about missing submission deadlines.
I’m concerned about the lack of staff with publishing skills.
I’m concerned that my team can’t cover the requirements of new regions.
I’m worried about the quality of submission documents from external authors.
I’m stressed that I can’t handle publishing tasks on top of my main responsibilities.
I’m unsure if external staff are familiar enough with our publishing tool.

A lack of in-house publishing expertise shouldn’t impact your ability to meet submission deadlines.

Efficient submission processing

Greatly reduce the time and effort needed to convert and submit documents.

Effortless regulatory compliance

Ensuring that every submission meets the strict standards set by authorities.

Manage costs efficiently

Eliminate the overhead costs associated with in-house processing of electronic submissions.

Secure and reliable data management

Maintain access and keep track throughout the process to maintain information integrity.

EXTEDO supports over 200 customers with its regulatory publishing and submission services. The team is experienced in the tools and processes required to create applications of all sizes.

"EXTEDO is a true partner for argenx. Since the start of our collaboration in 2019, argenx and EXTEDO have worked together in great collaboration with on-time delivery and exceptional quality."

Kristien Van Nimmen, Director Regulatory Operations at argenx

Your plan to effortless compliance

Schedule a call

We’ll discuss your publishing needs and review your challenges.

Outsource your project

Let EXTEDO’s team of experts take care of your publishing.

Publishing made effortless

Be confident that your submission deadlines will be met.

Take advantage of EXTEDO’s seasoned regulatory experts to effortlessly ensure timely and compliant submissions.

Without the necessary in-house skills and resources, publishing compliant documents and submissions can quickly become unmanageable.
EXTEDO provides regulatory publishing services to ensure you can submit high-quality submissions to the regulatory authorities within business deadlines.

Expertise

Regional and technical expertise

EXTEDO’s regulatory publishing and submission services support the following formats: NDA, sBLA, BLA, MAA, ANDA, eCTD, ePaper, Customized structures.
The service is structured into the following regions: Europe (Centralised, Decentralised, Mutual Recognition, National Procedures), Switzerland, USA, Canada, Australia, ASEAN, GCC and Rest of the world.

Publishing Support

Submission publishing support

Our personal approach means you consistently work with the same team, familiarizing yourself with those handling your application. We use our submission publishing software to create, validate, and directly publish your application to the relevant authorities. Optionally, we provide secure access for your team to view and review submissions.

Publishing Support

Document publishing support

Document publishing tasks consume much of the time spent on eCTD compilation—let EXTEDO streamline this for you. Our team prepares submission-ready documents tailored to agency standards, handling file conversions, bookmark additions, and hyperlink verifications. With EXTEDO's services, you're assured of 100% regulatory-compliant PDF documents consistently.

Services

Submission training

EXTEDO also provides personalized regulatory training courses. Built around the specific needs of your business, we will introduce you to the details of the electronic submission standards, help you develop lifecycle management processes, and take you through the steps necessary to publish your first submission through the electronic gateway.