Case Study PV

Case Studies.

Our company's success stories.
Medical writing, Non-clinical modules, Gap analysis
A Medical Writing project covering nine non-clinical modules (m2.4) for two products in different pharmaceutical forms and dosages.
Gap analysis, Submission strategy, Local liaison
Gap analysis, MAA, National registration
Swift support to meet deadline cover
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

What our clients say about us.

ICON plc

I would like to remark on your excellent collaboration with ICON; transparent communication style; timely escalation, responsiveness to the ICON team at all times. This project has encountered many challenges and you have been resilient and committed to the project throughout. Your professional conduct has been exemplary and I am truly grateful.

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