Dossier Submission Review
Manufacturers wishing to introduce their products into the European market may opt to do so via the Centralised Procedure. We offer regulatory and procedural guidance every step of the way.
EUQPPV and LCPPV Services
Marketing Authorisation Holders (MAH) in the European Union require the services of a Responsible Person for Pharmacovigilance (EU QPPV) resident in the EU to be able to head the pharma company’s team responsible for post marketing surveillance for all the medicinal products placed on the market. Post marketing surveillance includes the collection of reports of adverse events (serious and non-serious) which have to be forwarded to the MAH and the European Medicines Agency (EMA). The EU QPPV is assisted by local Qualified Persons for Pharmacovigilance (LCPPV) who are located in the individual countries where the medicinal products are marketed. The LCPPV carries out literature review and follows changes in national legislations relating to medicinal products and reports the findings of their research to the EU QPPV and MAH.
Post Marketing Life Cycle Management
Post marketing life cycle management (LCM) refers to the processes carried out by the MAH or an outsourced entity to ensure the quality of a medicinal product and the safety of the patient are ensured.
Typical product lifecycle activities include:
- Medicinal product application for authorisation via the national health procedures
- Direct Healthcare Professional Communication (DHPC)
- Variations to patient information leaflets (PIL) and summary of product (SPC)including Common European Submission Portal (CESP) submissions
- Preparation of documentation for CESP submissions
- Printing and readability testing
- Communication with national health authorities on behalf of MAHs
- Regulatory Intelligence for Pharmacovigilance