Vendor Qualification and Audit

Vendor Qualification and Audit
Product Description

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 audit.  We also have experience in managing bespoke audit requirements to assess technology transfer capabilities or to carry out an initial assessment of sites to GMP, GLP, GCP and GDP regulations.
For each project, we work with our clients to discuss their individual needs, review the company or site to be audited and determine the capabilities to be assessed and regulatory standards to be applied. If an on-site evaluation is required, we will work with our client to ensure the audit is booked and to identify the best auditor for the type of assessment.

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Orion GXP Consulting Ltd

  • Country/Region:
    Ireland
  • Founded:
    2021
  • On CPHI since:
    2023
  • Certificates:
    1
  • Employees:
    1 - 24
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
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Specifications
  • Details
    Vendor Qualification Strategy and Risk Assessment (Hourly Rate or Block of hours)On-Site Audits (Hourly Rate or PRiced per Audit)
    Remote Audits (Hourly Rate or Priced per Audit
  • Selling Points
    Quality Service
  • Supplied from
    Ireland; United Kingdom
More specifications Fewer specifications
Sales Markets
Show more Show less

Orion GXP Consulting Ltd

  • Country/Region:
    Ireland
  • Founded:
    2021
  • On CPHI since:
    2023
  • Certificates:
    1
  • Employees:
    1 - 24
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

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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
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    Brochure Orion GXP Consulting - MIA Import & Certification, Regulatory and Consulting support

    Orion GMP Consulting Ltd can manage your EU supply chain and onboarding for physical Import and complete Import and QP batch certification, allowing batch release into Europe. We also provide interim and contract QPs for clients with their own MIA and where our QPs can certify batches on behalf of the client.