Services

Supply Chain

  • Create drug supply strategies and timelines for sponsored clinical trials and external collaborations

  • Evaluate, select and setup Contract Manufacturing Organizations (CMO's)

  • Develop and manage forecasts and plan inventory accordingly

  • Select, setup and manage Interactive Response Technology (IRT) vendor(s)

  • Set up and manage global depot network

Packaging

  • Design primary, secondary and tertiary packaging (configurations and materials used)

  • Design container-closure integrity testing plans and methods

  • Execute process validation: equipment qualification (IQ/OQ), performance qualification (PQ)

  • Execute design qualification for package performance (distribution simulation and thermal qualification)

  • Develop packaging usability studies and human factor studies

Labeling

  • Create, implement and maintain of DS, DP and IP labeling strategies.

  • Plan and manage labeling content design, review and approval process for single panel/booklet labels (English label texts to label proofs)

  • Ensure label design can maintain adhesion at CRT, 2-8°C, -20°C, -70°C and -180°C

  • Design blinding techniques for comparators, co-dosing and when parenteral active and placebo show visual difference