We provide Development and Documentation of the Validation Protocols and Reports in compliance with current FDA and ICH Guidance.

• Method Development Services:

  • Identification
  • Assay testing
  • Testing for impurities
  • Stability indicating methods
  • Humidity/temperature
  • pH values
  • Oxidative and reductive stress
  • Light stressing
  • Microbial testing

• Method Validation Services:
  • Accuracy
  • Precision
    • Repeatability
    • Intermediate precision
    • Reproducibility
  • Specificity
  • Detection limit
  • Quantitative limit
  • Linearity
  • Range
  • Robustness
  • System suitability test
    

• Technology Transfer and Method Transfer Services:
  
  • Our Dedicated Staff will provide method transfer providing the following services
    • Providing detail documentation for tech transfer
    • Providing on site training for the method
    • Providing Certificate of Training and Tech Transfer

We begin a project by clearly defining objectives and potential technical approaches with you. Upon agreement of project direction, we outline tasks and timetables, including anticipated costs, in a project proposal. Efforts proceed only upon your authorization. We maintain a close working relationship and respect the confidential nature of the work being performed.

We guarantee our method development and validation. We provide 5 years Certificate of Grantee for the methods that are developed and validated by VLI.

For method Transfer, our technical staff will travel to your site to implement the method and technology transfer and train your technical staff.