eCTD Solution for Large Pharma Companies

A Story of Transformation in Regulatory Submissions

Managing complex lifecycle submissions across multiple regions is no small feat. Tight deadlines, compliance pressures, and high stakes leave little room for error.
One global pharmaceutical leader faced these same challenges. Instead of reacting to every roadblock, they chose to be proactive—and partnered with Freyr SUBMIT PRO.
The Results? A Benchmark in Regulatory Excellence:

  • Accelerate Go-to-Market Timelines

    Seamlessly Imported and Validated Over 30 Sequences

    Reduced manual intervention and submission bottlenecks.

  • Ensure Compliance and Approval Success

    Accelerated Submission Timelines by 10%

    Freed up valuable team hours for strategic tasks.

  • Expand into New Markets Confidently

    Reduced Errors by 20%

    Intelligent validation workflows minimized compliance risks.

  • 24x7 Dedicated Support

    Global Compliance Confidence

    Aligned submissions with USFDA, EMA, MHRA, and other regulatory bodies.

Today, they’re not just meeting deadlines-they’re setting new standards for regulatory submission excellence.

Your team deserves the tools and technology 
to excel in every submission.

Take the first step towards seamless, error-free, and 
compliant submissions.

Take the Lead – Book a Demo Today

What Our Clients Are Saying

 

Thank you Freyr for responding to our extremely pressing issue regarding SPL submissions. Though the requirement was on a short turnaround time failing which the application to the FDA had to be cancelled. You guys have worked it out without compromising. We are extremely happy to see your rapid response in sharing the package to FDA. The entire Freyr team has to be congratulated on being able to provide an important service in a very short period of time. Again, thank you for the unbelievable response to our pressing request.

Associate Director, Global Regulatory Affairs
A Global Specialty Generic Pharmaceutical Company
 

A huge thanks to Freyr Digital for the excellent support in turning around 100 (approx..) lit references, which were needed in a short period in support of a New Drug Application (NDA) submission. Really appreciate their dedication and hard work in making this possible. This is a critical submission for us and therefore I wanted to take the time to let you know that the submission team recognize your contribution and are extremely grateful for your support not only for these but also for the hundreds of reports, which you’ve republished to make submission-ready for this major submission.

Global Head of Regulatory Affairs
Switzerland based Global Pharma company
 

The SPLs looked good. And the response to one of our queries to handle combining/de-listing was also great

Associate Director, Global Labeling
An American multinational pharmaceutical company
 

Thank you so much. We appreciate the work spirit shown by Freyr to get things done whenever required on priority basis.

Deputy Manager, Regulatory Affairs
An Indian multinational pharmaceutical and biotechnology company

Proven Results, Tangible Impact

Accelerate and Empower
25+
Presence Across 25+ Countries
Accelerate and Empower
100,0000+
Submissions Managed
Accelerate and Empower
450+
Regulatory Experts
Accelerate and Empower
3,350+
Active Users Globally
Every number represents confidence, accuracy, and excellence achieved by our partners.

Lead the Change in Regulatory Submissions

Success in regulatory submissions isn’t about managing 
chaos-it’s about anticipating, optimizing, and excelling.
Let’s redefine how your team handles submissions, one 
sequence at a time.

Take the Lead – Book a Demo Today

Extensive Training and Support