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Pre-clinical Product Development

Client: Biotechnology Company, USA

Scope: Pre-clinical product development for an oral paste pharmaceutical product.

Outcome: Completed formulation development within five months

Service provided:
Analytical Development
  • USP IV dissolution
  • Potency and Related Substance Method


    • Formulation Development
  • Develop In-Vitro test model for oral paste product
  • Develop formulation for clinical trial and scale up
    		•
    Phase 1 Clinical Program

    Client: Biotechnology Company, Canada

    Scope: Phase 1 Clinical Program (CMC and Clinical)

    Outcome: Completed Project Planning and Patent Strategy within one month. Product development is actively progressing.

    Service provided:
    Project Planning
    Patent Strategy
    Product Development
    CT manufacturing
    Clinical Research (partner with CRO)
    Pre-formulation Studies

    Client: Start-up Pharmaceutical Company, Canada

    Scope: Select the best candidate for product development by investigating the critical physical and chemical properties of API (pre-formulation studies)

    Outcome: Complete the full pre-formulation study of two APIs within three months.

    Service provided:
    Intrinsic dissolution
    Ionization constant
    Differential Scanning Calorimetry
    Thermal Gravimetric Analysis
    Co-solvent solubility
    Analytical Development

    Client: Consumer Health Product Company (International)

    Scope: Develop a harmonized HPLC method for 13 different formulations (OTC products)

    Outcome: Completed all method development and validation within seven months. Methods transferred to the client’s laboratory.

    Service provided:
    Analytical method development
    Analytical method validation
    Analytical method transfer
    On-site technical support
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