Our People
Even though we are a bit on the geeky side, we speak your language.
We partner with first class Regulatory Affairs experts who create documentation necessary to obtain FDA, EMA, Health Canada and other agencies’ approval in order to market products in their respective jurisdictions.
We then generate electronic dossiers of the highest quality, optimized to make agency review times quick and efficient. We utilize best-in-class software and human talent to achieve extraordinary quality.
We:
* Put integrity and professionalism first
* Complete projects on time. Period.
* Thoroughly understand FDA requirements
* Are masters of technical topics
* Make it personal, not just business.
We deliver trusted assurance.
Technical Staff
We certify that all of our team will be dependable, efficient, accurate, timely, flexible and ready to meet your needs. Our team of experts can help you with:
* Full range of eCTD services
* SPL Creation & Submission
* ESG Transmissions & ESG account generation
History of Success
Our team has been doing electronic submissions in electronic Common Technical Document (eCTD) format longer than most people in the industry. In fact, we were the first to file a DMF electronically with FDA in 2004.
We have submitted thousands of eCTD, SPL, and eSubmitter applications for clients dotting the globe, covering ANDA’s, IND’s, NDA’s, DMF’s, and VMF’s.
In addition, we have mastered the fine art of filing electronic Structured Product Labeling (SPL) Establishment Registrations (and Renewals), NDC Labeler Requests, CARES data, FURLS registrations, and Drug Listings. We are also ready to help with the new MoCRA requirements for the cosmetic industry site registration and product listings. All are now required by FDA to be submitted electronically via an ESG Account.
Flexibility
We know that emergencies never happen between 8 and 5 Monday to Friday, and that our industry is truly global—so we are available when you need us most.
Regulatory Partnerships
With our regulatory associates, we bring over 60 years of combined experience preparing, validating, and submitting CTD and eCTD applications to FDA.
Contact Us
| Secure Submissions Inc. SSI Accounting Dept. accounting@securesubinc.com P.O. Box 856 Rye, CO 81069 Mike Bowler — Principal 719.243.2211 mbowler@securesubinc.com Kent Bowler — Principal 435.817.3855 kbowler@securesubinc.com |