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
Show more Show less

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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Intertek resources (1)