Regulatory

We maintain an in-depth awareness and understanding of Canadian and US regulatory requirements and will outline an appropriate regulatory strategy to minimize your product's time to market. Regxia offers a fresh problem-solving approach to all our customer’s needs. Our experience in a wide range of pharmaceutical and biologic regulatory activities allows us to provide timely advice and creative solutions.

Dossier Compilation and Management

Scientific and Strategic Consulting

Chemistry, Manufacturing, and Controls

Clinical Regulatory Support

TESTIMONIALS

"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