Orion Gxp Consulting

Orion GXP Consulting provides Manufacturer and Importers Authorisation (MIA) services, and expert consultants representing the industry's very best and to provide their clients with an unrivalled level of support. The Orion team often cover short-term expansion, remediation projects, or staff augmentation, where additional interim support is required to cover gaps within your organisation or leave. Orion strongly believes in delivering excellence in the pharmaceutical and medical device consulting landscape and is steadfastly committed to compliance with best practices in good manufacturing practices (GMP) and good distribution practices (GDP). We provide the following professional contract services, staff augmentation and consulting services to the healthcare industry: MIA import and EU batch certification for commercial pharmaceutical products. 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.