Product/Service

Phase I, II, And III Clinical Supply

Phase I,II, and III Clinical Supply

Upperton provides clinical supplies for Phase 1, Phase 2, and Phase 3, specializing in oral, nasal, and pulmonary dosage forms.

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Services include:

Phase 1-2 Clinical Supply:

  • Clinical Manufacturing: Production of clinical trial materials for Phases 1 and 2
  • QC Testing: Quality control testing to meet regulatory standards
  • ICH Stability: Stability testing following (ICH) guidelines
  • Qualified Person Release: Ensuring product release complies with regulatory requirements
  • Clinical Stability: Assessing the stability of clinical trial materials throughout development

Process Scale-Up for Phase 3:

  • Method Validation: Validating analytical and manufacturing methods for Phase 3 trials
  • Cleaning Validation: Verifying cleaning processes to maintain product quality
  • ICH Stability: Stability testing to support Phase 3 trials and registration.
  • QP Release: Ensuring final product release meets all regulatory and quality standards

Upperton Pharma Solutions