Regulatory Services
Registration strategy, submissions and lifecycle maintenance across regulated and emerging markets.
Our services
Six practice areas, delivered independently or as one integrated programme covering the full product lifecycle.
Pharmacovigilance
QPPV coverage, safety database management, PSUR/PBRER authoring and signal detection.
BE/BA Studies
Bioequivalence and bioavailability study design, CRO selection and oversight through final report.
CTD Dossier
Compilation, gap analysis and publishing of CTD and eCTD dossiers ready for agency review.
Translations
Certified pharmaceutical translation of labelling, SmPCs and technical documentation.
Supply Chain
Sourcing, GDP-compliant logistics and distribution through an integrated partner network.