CMC analytical support

CMC analytical support
Product Description

Leveraging state-of-the-art technology and rigorous scientific methodologies, we provide a full spectrum of CMC analytical support, including:

·         Method Development and Validation  

·         Cleaning Validation

·         Stability Testing

·         Dissolution Studies (including TIM1/TINY TIM gastro-intestinal model)

·         Orthogonal Methods Development 

·         Impurities Identification and Isolation 

·         Elemental Impurities Determination (ICH Q3D)

·         Nitrosamines Determination and Testing

·         Pyrrolizidine Alkaloids (PAs) Determination and Testing

·         Dioxins and Furans Analysis 

·         Glycols Analysis 

·         Extractables & Leachables Services

·         Microbiological Testing

·         Analytical Characterization 

·         Release Testing

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Selvita

  • Country/Region:
    Poland
  • On CPHI since:
    2020
  • Certificates:
    1
  • Employees:
    1000 - 4999
Company types
Contract Research Organisation (CRO)
Primary activities
Agrochemical
Analytical Services
Biopharmaceutical
Chemical Development
Contract Manufacturer
Custom Manufacturing/Custom Synthesis
Laboratory Services
Regulatory Affairs
View company profile
Categories
more categories Show less

Selvita

  • Country/Region:
    Poland
  • On CPHI since:
    2020
  • Certificates:
    1
  • Employees:
    1000 - 4999
Company types
Contract Research Organisation (CRO)
Primary activities
Agrochemical
Analytical Services
Biopharmaceutical
Chemical Development
Contract Manufacturer
Custom Manufacturing/Custom Synthesis
Laboratory Services
Regulatory Affairs
View company profile

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