Consistency to global application procedures

It is important to understand and define the clear regulatory strategy by considering the target markets/ regions, different patent terms and their extension, various application possibilities, data requirements, deadlines for launching products to be marketed in different markets/ regions.

Marketing authorizations for medicinal products are subject to very strict overall requirements. Preparing, submitting, and maintaining CTD/eCTD dossiers places considerable demands on a company’s human resources.

Our services include

  • Regulatory due diligence and strategy

  • Liaison with EU agencies

  • Support for local requirements

  • MAA dossier – full modules preparation

  • Dossier – due diligence and baseline preparation