We can offer:
Preparation of dossiers for submission for marketing authorisations.
Quality Overall Summaries, Licence variation, Centralised Technical Document (CTD) in e-format, Self Inspection/internal audit schedule preparation.
Support and guidance for European (MHRA) Inspections, USFDA Inspections, GCC (Gulf States), TGA (Australia), MCC (South Africa).
QP: Qualified Persons Services
All holders of a manufacturer’s licence for licensed products, including for the purposes of import, are required to have available the services of a Qualified Person (QP), who must be named on the licence. When considering a nomination, the licensing authority (the MHRA) routinely takes into account the assessment of the nominee’s eligibility made by the joint assessment panel of the Institute of Biology, the Royal Pharmaceutical Society of Great Britain and the Royal Society of Chemistry. Exceptionally, the MHRA will assess a nominee directly if he or she is not a member of any of these professional bodies.
Services are provided in compliance with the Code of Practice for Qualified Persons and all relevant EU Directives.