Providing Everything You Need
Regxia is proud to have implemented and validated an electronic submission system. With over 15,000 e-submissions to date, Regxia has a wealth of experience in the development of compliant e-dossiers and XML Product Monographs.
Regxia will guide you through the entire process and accelerate your transition to e-submissions. We will remain by your side during the agency review of the dossier and will help support you throughout the global lifecycle of your product.
Regxia is equipped to perform initial builds of your CTAs/INDs and NDSs/NDAs, manage life-cycle, and takeover existing e-dossiers, ensuring efficient submissions to Health Canada and the FDA.
XML Product Monograph
Regxia has stayed in close communication with Health Canada and SPL experts to remain at the forefront of being able to author Structured XML Product Monographs (PMs). Regxia utilizes a proprietary digital platform for preparing, managing and validating XML PMs that conform to Health Canada's requirements.
Our team makes the process simple, transforming your existing Word documents into a validated XML PM submission to Health Canada.
"I just wanted to say thank you very much for all of your help with getting our application prepared and submitted, and also with responding to the Agency's information requests since that time. A lot of work went into both the preparation and publication of these submissions, and we really appreciate Regxia's expertise and flexibility, expediting submission preparation where needed"
Director Regulatory Compliance
Small Pharmaceutical Company