At GLORAMP, our Qualified Person (QP) services ensure full compliance with EU and UK Good Manufacturing Practice (GMP) requirements — safeguarding product quality, integrity, and patient safety from batch release to market distribution.
Contract QP & Responsible Person support
Clinical and commercial batch certification/release (EU/UK), importation, and supply-chainoversight to GMP/GDP
GMP/GDP audits & remediation
Audits of CMOs, packaging/labeling, distribution (WDA) and temperature-controlled logistics perEMA/MHRA.
Tech transfer & validation
QP review of IMP/Commercial documentation, validation packages, and QMS alignment to Annexrequirements (e.g., Annex 1 sterile).
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