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!
Years of Combined Experience
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.
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.
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.
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.
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at a glance
Content preparation for successful submissions
Our Regulatory content services help customers gain momentum in the competitive life sciences landscape through improving quality and speed with advanced technologies. We understand that both the quality and speed of implementation is critical for meeting the requirements of the industry and setting your company ahead of the rest.
Driving your Submission strategy through insights
biomedion's Regulatory Services approach integrates technology, expertise, and insights built from years of experience to help biopharma companies exceed global compliance goals, reduce costs and get drugs to market faster.
Our offerings span the drug development continuum where our assistance with the creation of a regulatory strategy and development plan helps eliminate surprises, keep development on track, and ensure appropriate quality strategy at each step.