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cGMP Analytical Development

Analytical expertise that drives sound formulation and process development decisions

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cGMP Analytical Method Development Fact Sheet

Analytical Method Development, Validation, Stability and Testing

Analytical method development and validation provides data that drives critical decision making in drug development and manufacturing. Methods need to be robust, efficient and consistent. As an end-to-end solutions provider for integrated drug discovery and development, BioDuro has extensive analytical testing experience to support all phases of drug development from discovery to clinical trial material manufacture. BioDuro can provide analytical studies as standalone services, or support for drug development programs.

cGMP Analytical Development

Validation services to ensure high quality of products:

  • Method evaluation
  • Method optimization
  • Method transfer
  • Method development
  • Phase-appropriate method validation

Stability/QC Testing

Evaluation of product and material stability according to ICH guidelines:

  • Release testing of raw materials
  • Release and stability testing of drug product/Clinical Trial Material
  • In-process testing during manufacturing
  • Stability program management, testing and storage
  • Cleaning verification