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.