Orion GXP Consulting

Orion GXP Consulting, a pharmaceutical manufacturing consultancy in Manorhamilton, Co. Leitrim, provides EU market entry support for non-EU companies. They offer interim Qualified Person and Responsible Person services, holding a Manufacturing and Importation Authorisation (MIA) in Ireland, which permits the legal importation and release of medicinal products into the EU market. Their services include MIA importation and batch certification, Qualified Person certification under EU GMP Annex 16, and importation controls aligned with EU GMP Annex 21. They also support new marketing authorisation applications, GMP and GDP compliance, and quality and regulatory projects.