Regulatory Services

Elara Pharmaservices Europe with the support of our sister company Callisto Consulting can assist you with Human, Veterinary and Herbal medicines in:

  • Preparation of regulatory dossiers for the UK, Europe and other markets.
  • Management of national, EU mutual recognition and decentralised licensing.
  • Preparation and signature of Quality Overall Summaries, Nonclinical and Clinical Overviews.
  • Preparation of Risk Management Plans and Environmental Risk Assessments.
  • Preparation of applications in vNeeS and eCTD format and ‘Due diligence of dossiers’.
  • Life cycle management including all types of variations, renewals and Change of Ownership applications.
  • Preparation of SmPCs, labelling and leaflets and PIQU submissions.
  • Reclassification applications.
  • Applications for Certificates of Suitability via EDQM.
  • Liaison with Regulatory Authorities including attendance at Scientific Advice Meetings.
  • Sunset Clause applications.


Extensive experience of human and veterinary medicines, medical devices, general products, herbal medicines, borderline products, food supplements and cosmetics.

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