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Services

Project Evaluation

 

  • Scientific strength

  • Competitive market

  • Risk assessment

  • Due diligence

Program Strategy

 

  • Preparation of strategic plan to reach next steps in corporate objectives

  • Budgeting

    • For funding process

    • For completion of objectives

  • Preparation of application documents for government grants and funding

Implementation

 

  • Set up virtual and/or in-house operations

  • Tech Transfer to CRO

    • Synthesis

    • Formulation

    • Analytical methodologies

  • Manage production process

Chemistry, Manufacturing and Control

 

  • Contract and manage preliminary and GLP tox batches

  • Contract and manage GMP production

  • Drug product manufacturing (specialize in lyophilized product)

  • Work with CMO to optimize analytical chemistry

  • Set up and manage storage stability and compatibility studies

  • Preparation of CMC documentation

    • FDA and Health Canada​

Small Molecules, Peptides and Protein Products
  • Compound design

    • Optimize activity

    • Improve metabolic stability

    • Improve pharmacological profile

    • Improve water solubility

  • Formulation recommendations (specialize in IV and SC)

  • Assess purity/activity specifications for CMC

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