Regulatory Submission Publishing Services - Stop Regulatory Submission Frustration | EXTEDO

Stop Regulatory Submission Frustration

Let us handle your regulatory submission publishing and free yourself for strategic tasks!

Tired of submission headaches? Meet the solution

EXTEDO's Regulatory Submission Publishing Services.

Say goodbye to the stress with EXTEDO's Regulatory Submission Publishing Services: Our comprehensive services are designed to simplify the entire process, ensuring compliance and timely delivery, every time. EXTEDO's teams in the US and Europe provide you with regulatory excellence 14 hours a day.

Our services cover everything you need for successful submissions, from document preparation to submission publishing. Whether you're just starting out or seeking to streamline your process, we've got you covered.

  • Project Management and Regulatory Consulting - benefit from expert guidance
  • Document and Content Publishing - ensure accuracy and compliance
  • Preparation of Regulatory Submissions –receive your NDAs, MAAs, ANDAs, BLAs, INDs, DMF, sBLAs, Ad Promo, AR, etc. on time and error-free
  • Submission Publishing - navigate regulatory requirements effortlessly
  • Submission to the Health Authorities and Assistance in ESG Account Creation - simplify your submission process
  • Quality Control - our holistic approachdefines regular quality controls at key steps in the process

Maximize efficiency and guarantee compliance

With EXTEDO, you take control by addressing the challenges of regulatory submission publishing head-on. Our tailored services ensure:

  • Expertise

    Trust our experienced team who know how to handle every aspect of the publishing process.

  • Compliance

    Staying ahead with the latest regulatory requirements, we ensure your submissions are always compliant.

  • Timeliness

    Deliver your submissions on schedule without compromise, thanks to our efficient processes and dedicated team.

  • Ease of use

    Our services streamline the entire process, making submissions effortless and hassle-free for you – leaving you more time for enhanced regulatory strategic planning or risk management measures.

Ready to experience quality? Enjoy a special discount on your first submission!

Unlock the full potential of your regulatory journey with EXTEDO.

  • #StopRegulatorySubmissionFrustration in the US:
    Enjoy 20% off your first US submission and make your mark in the American market!
  • #StopRegulatorySubmissionFrustration in the EU:
    Enjoy 15% off your first EU submissionand elevate your presence in the European market!
  • PLUS: Each of these offers comes with two full hours of Regulatory Submission Training included!

Request your individual service offer now!

Not convinced yet? See for yourself how argenx found the perfect match in our services for managing their overall publishing project.
"As a start-up, we welcomed the experience and support from EXTEDO. Their staff helped us to complete our first submission and get the application approved within a very demanding timeline."
Kristen Van Nimmen,
Director Regulatory Operations at Argenx
Download Case Study with Argenx

Resources

— Webinar

“The Nitty, Gritty Details of Regulatory Publishing”

See how our team works to deliver regulatory excellence and watch the recording of our webinar.
Watch the recording
— Case study

A trusted submission publishing partner for argenx

Download the full case study to learn, how EXTEDO, with its regulatory publishing software and services, proved to be the perfect match for argenx.
Download case study
— Service interview

Meet our Regulatory Publishing Services

Read the full interview, in which our Regulatory Publishing Services tell us, which tasks they cover, which projects they like to take on the most, and, of course, how their colleague eCTDmanager supports them.
Read interview
Learn More About Regulatory Submission Publishing