What Canta CMC Solutions Offers

Chemistry, Manufacturing and Control

Chemistry, Manufacturing and Control (CMC) is key to the successful delivery of a new medicine to the clinic, the market and the patient.

Services we offer:

  • CMC programme management
  • Analytical method development strategies
  • Analytical method validation strategies
  • Analytical method technology transfer strategies

Regulatory Support

Defining the right regulatory strategy for each phase of development is important in ensuring the new medicine has the best chance of receiving regulatory approval.

Services we offer:

  • Regulatory strategy development
  • Regulatory module authoring and review

Shelf life and Stability

An understanding of appropriate storage conditions and shelf life are essential for delivery of a safe, quality medicine to the patient.  Knowledge of the extremes to which a new medicine may be subjected without compromising its quality are important in managing any excursions that occur during transport or at the clinic.

Services we offer:

  • Stability study design and management
  • Data interpretation and understanding

Reference Standards

The establishment of suitably characterised reference materials is necessary to manage the quality of a new medicine.  This is also important for analytical method development and validation activities.

Services we offer:

  • Reference standard establishment
  • Reference standard management guidance