Drug Stability Testing and ICH Storage Outsourcing

Drug Stability Testing and ICH Storage Outsourcing
Product Description

Testing of pharmaceutical stability and ICH storage outsourcing: Our extensive capabilities cover all ICH conditions (or custom conditions), including climate control walk-in chambers, cabinets, refrigerated and freezer storage that are fully monitored and controlled, with backup units at every location. We have 24-hour alarm systems at all sites with dedicated teams on call to respond to excursions from storage conditions and over 375000L of storage capacity. We provide storage only or real-time or accelerated stability testing integrated with our analytical method development and validation and release testing teams.

In addition to providing professional stability management for outsourced storage, we can offer good manufacturing practice (cGMP) stability programs for the most complex dosage forms including oral inhaled and nasal drug products (OINDP), biopharmaceuticals, consumer healthcare, medical devices, and vaccines. Also, we provide a responsive and tailored stability contingency and disaster recovery storage service, which reduces the risk of costly stability trials.

To learn more, visit our website:

www.intertek.com/pharmaceutical/analysis/stability

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Intertek Analytical Services

  • GB
  • 2015
    On CPHI since
  • 4
    Certificates
  • 1000 - 4999
    Employees
Company types
CMO/CDMO
Consultancy
Contract Research Organisation (CRO)
Contract Service
Drug delivery device Supplier/Manufacturer
Manufacturer/Innovator
Primary activities
Analytical Services
Contract Research Organisation
Laboratory Services
Medical Devices
Packaging & drug delivery
Supply Chain
View company profile
Categories
more categories Show less
Specifications
  • Selling Points
    Experienced Technicians; International Approvals/Standards; Product Performance; Quality Service; Reputation
  • Supplied from
    Australia; United Kingdom; United States
  • Measured In
    litre
More specifications Fewer specifications
Sales Markets
Show more Show less

Intertek Analytical Services

  • GB
  • 2015
    On CPHI since
  • 4
    Certificates
  • 1000 - 4999
    Employees
Company types
CMO/CDMO
Consultancy
Contract Research Organisation (CRO)
Contract Service
Drug delivery device Supplier/Manufacturer
Manufacturer/Innovator
Primary activities
Analytical Services
Contract Research Organisation
Laboratory Services
Medical Devices
Packaging & drug delivery
Supply Chain
View company profile

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    In this webinar, our expert, Dr Tino Otte, Head Consulting at Intertek in Switzerland, discuss extractables and leachables studies which have been performed on multiple product types and contact materials. With increasing focus by the authorities on the accurate determination of leachables in real formulations, one of the biggest challenges is to differentiate between matrix related degradation products and real leachables from the packaging or contact materials. Typical examples and case studies will illustrate how, through a strategic approach, it is possible to differentiate between the two. Furthermore, these case studies will illustrate why it is important to analyse leachables in the actual formulation and not only in extraction solutions.
  • WEBINAR - Analytical Approaches for Identification and Quantification of Impurities In Pharmaceuticals

    Video WEBINAR - Analytical Approaches for Identification and Quantification of Impurities In Pharmaceuticals

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  • WEBINAR - Repurposing Products for Inhaled Delivery - Rapid Response Strategies

    Video WEBINAR - Repurposing Products for Inhaled Delivery - Rapid Response Strategies

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