GxP Training Services
Product Description
Orion GXP Consulting Ltd
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IE
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2023On CPHI since
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1Certificates
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1 - 24Employees
Company types
Primary activities
Categories
Specifications
Orion GXP Consulting Ltd
-
IE
-
2023On CPHI since
-
1Certificates
-
1 - 24Employees
Company types
Primary activities
More Products from Orion GXP Consulting Ltd (4)
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Product Contract QP, RP and RPi Services
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... -
Product QMS Authoring and Licencing Support
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... -
Product Regulatory, CMC and MA sourcing
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... -
Product Vendor Qualification and Audit
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 ...
Orion GXP Consulting Ltd resources (2)
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News What crucial questions demand your attention when completing a Marketing Authorisation Transfer (MAT)?
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- -
Brochure Orion GXP Consulting - People and Services
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!
Position your company at the heart of the global Pharma industry with a CPHI Online membership
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Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
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Generate high-quality, engaged leads for your business, all year round
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Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
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Your company’s profile boosted at all participating CPHI events
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An easy-to-use platform with a detailed dashboard showing your leads and performance