Filing Services

We can provide selected resources and support as you undertake procedures, or manage the entire cycle from the compilation of application forms through to obtaining marketing authorization.

Our services include:

  • Abridge applications for generic products
  • Bibliographic applications
  • National, Mutual Recognition, Centralized and Decentralized Procedures
  • Variations to marketing authorizations (including Type I and Type II variations for marketing authorization updates)
  • Renewal of marketing authorizations in the EU

Case Studies

Discover how our services work in action

Decentralised Procedure

This leading pharma company used elc group to achieve EU marketing authorizations for a new cardiac treatment.

Mutual Recognition Procedure

elc group helps a pharma company fast track EU marketing authorization for a neurodegenerative disease drug.

Biowaver submission

This pharma company turned to elc group to navigate EU biowaver approvals for a new generic drug.