Let's Work Together at Any Stage from Discovery to Post-Marketing

biomedion has a talented Regulatory Operations team that creates a partnership with customers to ensure high quality regulatory submissions to various Health Authorities.  Our team specializes in working with small to mid-sized pharmaceutical and med-device companies. We provide A-to-Z expertise which includes Word Templates, Word Formatting, eCTD guidance/advice, eCTD compilation, submission through ESG, and Quality Checks of other outsourced work. If you have a regulatory need, we are happy to help!


Get a free Regulatory consultation
Our Regulatory content services help customers gain momentum in the competitive life sciences landscape through improving quality and speed with advanced technologies. 


Years of Combined Experience

10 k+

Sequences Processed

20 +


90 %

Client Retention

300 +

AdPromo Submissions

Canva Design DAFXieaTIkA

Document Formatting

We can provide various document formatting options depending on your needs. Whether it be continuous or ad-hoc. Our team is able to assess and fix your word documents so they adhere to Agency guidelines. We provide document publishing that is submission ready with realistic timelines. 

Canva Design DAFXifn7Jgo

eCTD Compilation

Our eCTD compilation includes everything from providing a regulatory management system (iRCS) to submission through the ESG gateway.  We can convert your paper applications to eCTD format.  Need help with your US, EU or Canada based submission?  We've got you covered.

Canva Design DAFXiXyFB8w

Regulatory Guidance

Not sure what to provide in a submission?  Is eCTD new or do you need a refresher?  Has your submission and document life-cycling process been a bit unbearable?  Is the new BIMO requirement in eCTD not making sense? Our team can provide you with an introductory course on all things regulatory or training on any topic that may be of some confusion to you.

Canva Design DAFXic3Wv-w

Regulatory Quality Check

Have you provided another vendor with your regulatory needs and you'd like a QC? Send it our way for a complete review and analysis of the application and/or submission package.  

Services trusted by

Are You Ready to Collaborate?

Contact Us For A Free Regulatory Consultation Today!

More services