Regulatory, CMC and MA sourcing

Regulatory, CMC and MA sourcing
Product Description

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 health authorities such as the MHRA and HPRA.

Our team can undertake client PV support requirements or perform specific tasks where the client may have a lack of resources.  We are able to offer a range of services, including RMPs, collation and follow-up on ADRs, literature searches, reporting to HA.

Read more Show less

Orion GXP Consulting Ltd

  • IE
  • 2023
    On CPHI since
  • 1
    Certificates
  • 1 - 24
    Employees
Company types
Consultancy
Contract Service
Distributor/Import Export
Generics/Biosimilars Manufacturer
Start-up
Wholesale/Retail
Primary activities
Biopharmaceutical
End-product distributor (Wholesale)
Finished Formulation products Distributor/Buyer
Marketing Services Provider
Medical Devices
Out-licensing specialist
Packaging & drug delivery
Regulatory Affairs
Supply Chain
Transport/Logistics/Distribution
View company profile
Categories
more categories Show less
Specifications
  • Selling Points
    Quality Service
  • Supplied from
    Ireland; United Kingdom
More specifications Fewer specifications
Sales Markets
Show more Show less

Orion GXP Consulting Ltd

  • IE
  • 2023
    On CPHI since
  • 1
    Certificates
  • 1 - 24
    Employees
Company types
Consultancy
Contract Service
Distributor/Import Export
Generics/Biosimilars Manufacturer
Start-up
Wholesale/Retail
Primary activities
Biopharmaceutical
End-product distributor (Wholesale)
Finished Formulation products Distributor/Buyer
Marketing Services Provider
Medical Devices
Out-licensing specialist
Packaging & drug delivery
Regulatory Affairs
Supply Chain
Transport/Logistics/Distribution
View company profile

More Products from Orion GXP Consulting Ltd (4)

  • Contract QP, RP and RPi Services

    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...
  • GxP Training Services

    Product GxP Training Services

    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...
  • QMS Authoring and Licencing Support

    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...
  • Vendor Qualification and Audit

    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)

  • What crucial questions demand your attention when completing a Marketing Authorisation Transfer (MAT)?

    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-
    22 Aug 2024
  • Orion GXP Consulting - People and Services

    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!