GMP and CMC Laboratory Services

  • GMP and CMC Laboratory Services 1
  • GMP and CMC Laboratory Services 2
  • GMP and CMC Laboratory Services 3
Product Description

We provide regulatory-driven, phase-appropriate laboratory services in support of CMC programs seeing you through pre-formulation, formulation and product release. Our capabilities include centers of excellence for method development and validation, analysis, stability studies, extractables and leachables, solid state characterization, cGMP quality control testing and cGMP batch release testing. Our teams have specialist expertise for complex medicines and drug delivery systems such as inhalation drug product development for pulmonary and nasal products or biologic therapeutics.

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Intertek

  • US
  • 2017
    On CPHI since
  • 4
    Certificates
  • 5000+
    Employees
Company types
CMO/CDMO
Contract Research Organisation (CRO)
Contract Service
Primary activities
Analytical Services
Biopharmaceutical
Contract Research Organisation
Laboratory Services
Medical Devices
Packaging & drug delivery
View company profile
Categories
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Specifications
  • Details
    We provide regulatory-driven, phase-appropriate, CMC laboratory and GMP pharmaceutical laboratory services. Our expertise ensures sufficient information for your Investigational New Drug (IND), Abbreviated New Drug Application (ANDA) and New Drug Application (NDA) filings. This is achieved through analysis services, pre-formulation and solid-state characterisation, method development and validation, stability studies, pharmaceutical impurity analysis, extractables and leachables and GMP batch release testing. Our scientists are adept at applying advanced technology in GMP compliant analytical development programs. 
  • Selling Points
    Experienced Technicians; International Approvals/Standards; Prompt Delivery; Quality Service; Located in Whitehouse, New Jersey, USA, is a contract consulting analytical research and development laboratory and Good Manufacturing Practice (cGMP) compliant facility. We specialize in method development and validation, stability, trace organics, elemental impurities, and quality control testing.
  • Supplied from
    Australia; China; India; Switzerland; United Kingdom; United States
More specifications Fewer specifications
Sales Markets
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Intertek

  • US
  • 2017
    On CPHI since
  • 4
    Certificates
  • 5000+
    Employees
Company types
CMO/CDMO
Contract Research Organisation (CRO)
Contract Service
Primary activities
Analytical Services
Biopharmaceutical
Contract Research Organisation
Laboratory Services
Medical Devices
Packaging & drug delivery
View company profile

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  • Stability Testing

    Product Stability Testing

    With a network of ICH stability storage facilities in the UK, US and Australia, we offer an extensive capacity and a range of conditions including climatic walk-in chambers, cabinets and refrigerated as well as freezer storage, covering all ICH stability conditions. These are fully controlle...
  • Extractables and Leachables Testing

    Product Extractables and Leachables Testing

    Our experts have over 30 years of experience in specialized analytical and toxicology assessment for extractable leachable testing. Intertek offers extractables and leachables testing services through GMP-compliant laboratories located in Whitehouse, NJ (USA) and Basel (Switzerland) wit...
  • Inhalation Drug Product Development Services

    Product Inhalation Drug Product Development Services

    Our pharmaceutical auditing and management services give you a transparent view of your supply chain enabling you to identify and mitigate the intrinsic risks in your operations, supply chains and business processes. Through our shared audit programs, delivered by our global network of specialist ...

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