Fully aligned manufacturing technologies from early development to industrial scale provide the basis of success of your development and optimise time to market. As early in your project as possible, our goal is to establish a process that sets you up for process validation and commercial success. 

The services include but is not limited to:

  • Scale up/adaptation of batch size to meet customers requirements
  • Evaluation of critical process parameters
  • Guidance on process validation strategy
  • Performance of process validation
  • Analytical method validation
  • Manufacturing of registration batches
  • ICH stability testing
  • Supportive stability studies (In-use stability, bulk stability…)
  • Regulatory Services