Case Study PV

Case Studies.

Our company's success stories.
Local liaison, GVP auditing, CAPA reporting
Ensuring local quality meets global expectations TH
Audit support, documentation collection and preparation
Expert support delivered TH
ICSRs, Local literature screening, Regulatory intelligence
Strategic Planning case study
Inspection preparation and support, LPPV
Inspection preparation, inspection support, collaboration, communication, LPPV.
License renewal, National phase management, Translations
License renewal, national phase management, regulatory affairs, translations
DCP, EU market authorization, regulatory strategy
DCP, EU market authorization, SmPC, Medical literature search, CMS, RMS, therapeutic indications, APIs Suppliers, Local QP, local literature searching, ICSR processing, local HA, regulatory intelligence
WDA application, MHRA inspection, GDP certificate
WDA application support, GDP certificate support, MHRA inspection support, internal audit and creation of a QMS, placement of a QP, preparation of the Quality Manual and Technical Agreement, creation of the Master File.
Local literature search, ICSR processing, Regulatory intelligence
A bespoke cloud based system TH
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What our clients say about us.