Orion GXP Consulting Ltd

QPs are available to be listed on client MIA/MIA-IMPs and carry out batch release according to Directive 2001/83/EC (Human), Regulation (EU) No 536/2014 (clinical) and Regulation (EU) 2019/6 (veterinary).For GDP and distribution, we provide interim RP and RPi services to the pharmaceutical indust...

We work with our clients to ensure that the correct quality culture is embedded in their organisation by training the staff in the core principles of GMP, GDP, or other GxP industry practices.  When your employees understand the core principles of your quality system and the consequences of non-c...

We can help you design and implement effective quality management systems that comply with current EU and UK GxP standards.

 An effective QMS will consist of all of the business processes, personnel responsibilities and standards including manuals, policies and procedures required to...

We provide regulatory and PV services, which can be tailored to suit individual client needs.
Our regulatory support includes Marketing Authorisation sourcing, MA transfer, ongoing licencing support, CMC authoring and preparation of type I and type II variations and submission to EMA and national he...

Our pool of auditors have experience in a wide range of dosage forms and processes, medical devices, API, Excipient, laboratories, storage sites and service providers.  Each auditor is selected according to their expertise and experience and is assessed for suitability before engaging in a client ...

We wanted to celebrate our new look website and everyone hopefully having their summer break by now! What better way to celebrate that than with an educational and informative article on the important questions to ask when conducting a Marketing Authorisation Transfer (MAT)? I will guide you through some of the pitfalls in dealing with MAT transfers, whether you are dealing with the divestment of a portfolio or just acquiring a single licence. Happy reading!

https://oriongxp.com/article/what-are-the-top-questions-that-you-need-to-ask-when-completing-an-marketing-authorisation-transfer-mat-

Whether for a short-term requirement in a particular GXP discipline (dossier or QMS remediation) or if you need a QP or RP to go on a licence, we can help!