ABOUT US

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.

Take a look at our Company Brochure for an overview of who we are and what we do!

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

storage and distribution

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.

Our history & growth in the last 20 years

2024

Moving into larger offices at the begining of the year we are now nearly 40 employees. Callisto projects continued growth over the next 5 years throughout the range of services.

2023

Callisto continued growing rapidly, with its workforce growing to encompass 30 full time members of staff and its client base increasing to more than 100 organisations based across the globe.

Callisto also attended its first CPHI networking event in Barcelona.

2022

All the individual companies within the group were rebranded to trade under the name Callisto Pharma Group. The change of trading name was part of the group’s strategy to emphasise the strength of its offering across the complete pharmaceutical & medical device supply chain.

A new office was also acquired in Ireland.

2019

To support its continued expansion, Callisto Relocated its UK office to a larger site.

2018

Elara Pharmaservices Europe Limited was founded and incorporated in Ireland, enabling the group to continue to provide services into Europe following the UK’s departure from the European Union. The business held all relevant licenses supporting the delivery of all servuces to UK & overseas clients.

2012

In response to the demand for import and batch release services, Elara Pharmaservices Limited was founded, which held the necessary MIA & ManA to facilitate the delivery of these services.

2006

As its workforce continued to expand, the company established its first dedicated commercial office.

2003

Having identified a potential gap in the market for consultancy services for MA holders outside of large pharma companies the company, then named Callisto Regulatory Consulting Limited, was incorporated.

OUR VALUES

We invest in our people and infrastructure to enable us to be highly flexible, efficient and innovative.

We are proud of our heritage which is one of technical excellence and strong core values.

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