Clinical Supplies Production And Management

Keata can provide support for domestic and international clinical trials from pre-clinical to Phase I to IV through a number of activities:

• Formulation development, clinical supplies dosage manufacturing, and procurement of all supplies
• Primary and secondary packaging, and kit assembly, including individual patient packaging and blinding
• Logistics management and coordination of clinical supplies including:
  • Storage
  • Shipping, tracking, and delivery confirmation
  • Returns, and supply/ usage reconciliation.
• Regulatory support for the company and/or the Clinical Research Organization:
  • Preparation of the chemistry and manufacturing data for clinical trial application
  • Extension of expiry date
  • Filing of notifiable changes and supplements
  • Technology transfer