Regulatory Affairs Services
 

Whatever the scale or complexity of your project, Regulus has the contacts and the knowledge to maximize your chances of success with regulatory authorities across the world. Our team offers expert advice and produces high-quality submissions, giving you access to the widest possible market in the shortest possible time. We have developed strong relationships with the US Food and Drug Administration and European Authorities, and regularly represent our customers at critical agency meetings.

Our experience encompasses international clinical trial approvals and registrations of new chemical and biological entities and pharmaceutical products containing established active ingredients (generics). We develop high-level regulatory strategies to expedite products through clinical trials and onto the market.

 
US and Canadian Registration
Frequent, direct interaction with the US Food and Drug Administration puts us in a strong position when preparing and submitting investigational new drug applications and US marketing applications for pharmaceutical, biotechnology, and generic products. Regulus can assist you with clinical trial applications and product registrations in Canada. We also have extensive experience writing Drug Master Files for international product registrations.

European Registration
Using the Common Technical Document format and following mutual recognition or centralized procedures, we can manage the entire European registration process for new medicinal products as well as for generic products. We can prepare clinical trial applications for countries in Europe and elsewhere in the world.

International Orphan Drug Registration
European and US legislation provides attractive incentives for companies to develop orphan drugs to treat rare diseases. Regulus can assist you with your international orphan drug programs, developing expeditious and creative registration strategies, preparing designation applications, and securing clinical trial and marketing approvals in both Europe and the US.

Summary of Regulatory Services
  • CTAs/INDs/MAAs/NDAs
  • Variations/Amendments/Reports
  • Sections of Drug Applications (CTD format)
  • Electronic Publishing and Dossier Compilation
  • Label Review
  • Mutual Recognition and Centralized procedures
  • Orphan Drug Designation Applications
  • Regulatory Authority Meetings
  • Regulatory Due Diligence
  • US Agent