BUILDING THE FUTURE
Callisto Pharma Group has grown from the formation, in 2003, of Callisto Regulatory Consulting Ltd, which provided regulatory and technical support to pharmaceutical manufacturers. Callisto has developed into a consultancy group that can provide a complete range of technical services across the whole supply chain within multiple regulated sectors including human, veterinary and herbal medicines, borderline products, biocides, medical devices and food supplements.
We work across the UK, Europe, and the rest of the world for clients operating in highly regulated sectors, ranging from global multi-nationals to single product licence holders.
Within the group we can provide product release and QP Technical support to manufacturers and licence holders. The group holds both an MIA and ManA granted by the MHRA to enable us to support clients wishing to import Licensed Human & Veterinary products into the UK.
An Irish group company was established 2018 in response to the UK’s Brexit preparations to ensure continued service for many of our clients. We now also hold an MIA, VIA and WDA granted by the HPRA and, in conjunction with our UK licences we maintain a European (EEA) footprint.
A SUMMARY OF OUR IN-HOUSE SERVICES INCLUDE:
Preparation and submission of regulatory dossiers
Regulatory variations and Life-Cycle Management
Full technical support to manufacturers, including technical transfer, manufacturing process, development projects and analytical trouble-shooting
Complete Pharmacovigilance Services including QPPV and EU QPPV appointment
Importation into the UK & EEA under our UK and EU based licences
Holding Marketing Authorisations (MAs) on behalf of our Clients
Act as storage and distribution partner in accordance with GDP
Qualified Person (QP), Responsible Person (RP) and Responsible Person Import (RPi) services and consultancy including batch release activities
Quality Assurance & Control
GMP, GDP and PV auditing
Readability testing of labels and leaflets
Provision of training across all areas
Callisto Pharma Group has been built around the values of passion and commitment – our passion for what we do and our committed focus on our clients. Our passion and commitment drive the high quality, personalised services we deliver to each of our clients. We remain flexible to the changing needs of our clients and the ever changing regulatory environment we operate in.
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