Our Services...

Shore Ltd provides regulatory support for all areas of drug development and registration to facilitate successful filings in the EU:

  • Development plans to optimise successful filings (EU national, centralised, (CTD), Decentralised and Mutual Recognition)
  • Filing strategies
  • Guidance on clinical trial applications across Europe and other ROW territories
  • Advice on meetings with EU agencies including national EU agencies and the EMEA
  • Preparation of submissions to regulatory agencies for generic products, new chemical entities and biotechnology products
  • Preparation of Quality Overall Summaries
  • Re-formatting of dossiers into CTD format
  • Scientific advice applications
  • Preparation of Packaging and Labelling
  • Product License transfers
  • Due Diligence
  • Life-cycle management of new and existing products