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Orion GXP Consulting

Orion GXP Consulting

制药业

GxP consulting for the pharma industry - QP/RP services, Licensing, QMS development, auditing, GxP training and support.

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关于我们

Orion GXP Consulting is a pharmaceutical GMP and GDP consulting service with broad experience in quality and regulatory oversight of the import, manufacture and distribution of medicinal products. Our expertise includes solid and liquid oral dose, topical creams/ointments, ophthalmic products, aseptic fill finish, and terminally sterilised products. We provide the following professional contract services, staff augmentation and consulting services to the healthcare industry: Qualified Person according to Article 48 of Directive 2001/83/EC. Responsible Person according to EU GDP guide (2013/C 343/01). GMP and GDP Mock inspections, site audits and vendor qualification. Pharmaceutical QMS development, implementation & embedding. Training on key disciplines such as Root Cause Analysis, Batch review, Auditing, Data Integrity and Quality Risk Management. Pharmaceutical MIA and WDA licence application support. Due diligence and gap analysis for mergers, acquisitions, and carve outs.

网站
https://www.oriongxp.com
所属行业
制药业
规模
2-10 人
总部
UK and Ireland
类型
私人持股

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