Recent and Current Projects
Below are some examples of projects undertaken by Rephine that will help to illustrate the types of services we can offer:-
Completed Projects
- Major consultancy exercise for new oral solid dose plant (South Africa).
From construction to production, including concept design, specification, project planning, quality systems design, validation and assistance with EU registration
- Interim management of sterile clinical trials material production unit for major multinational (UK)
- Interim management of pharmaceutical instrumentation service
company (UK)
- Quality management for phase 1 and 2 clinical trials of novel drug delivery system (UK).
- Enterprise document management system implementation support and validation
- Concept design and specification of high potency production facility (Ireland)
- Preparation of qualification documentation for major UK equipment supplier
- Consultancy contract to bring manufacturing facility into MHRA compliance (UAE)
- Commissioned audits of contract research organisations
- Commissioned audit of contract packaging organisation
- Due diligence – contract packaging facilities
- Review of laboratory facilities in Ireland
- Development of Quality Systems for IMP manufacturer leading to IMP license (Ireland)
Current Projects
- Development of quality system for a biometric group
- Continued Supplier Audits under the PharmAssess™ service
- Roll out of PharmAssess™ in India
- Q.P. support for virtual research company (Switzerland)
- Q.P. support for IMP manufacturer (Ireland)
- API dossier assessment (Switzerland)
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