Services

Abridged applications

We provide support for abridged marketing authorisation applications in Europe, including generics, hybrids, herbals, new fixed combinations, biosimilars, and informed consent applications. We assist clients throughout the process, from candidate selection and early product development through to marketing authorisation and lifecycle management.

  • Provide regulatory intelligence
  • Perform due diligence on in-licensing candidates and/or gap analysis on in-house developments
  • Provide technical advice to development project teams, on regulatory aspects of dosage form, excipient and container closure system choices, specification setting, bioequivalence study design, biowaivers, stability studies, risk assessments and much more
  • Advise on legal basis for submission and appropriate reference products
  • Advise on regulatory strategy and choice of regulatory procedure (centralised, decentralised, mutual recognition, national)
  • Provide in-country support as and when required
  • Assist with scientific advice processes
  • Communicate with competent authorities on behalf of the applicant
  • Author submission documents and expert reports
  • Publish (eCTD) and submit via CESP or other portals
  • Project manage the entire regulatory process through to approval, cooperating closely with the sponsor’s in-house team, suppliers, manufacturing sites and contractors
  • Advise on responses to competent authorities during assessment
  • Lifecycle management following marketing authorisation (see Product Lifecycle Management)
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