Drug Development

SDS expertise spans the whole drug development paradigm for small molecules and biologics including vaccine, new modalities and ATMP´s, from formulation development and design of non-clinical program to regulatory strategies and clinical study design. We can help you complete a specific task within your project or we can take full responsibility for the project and guide you through the whole development program. Our assigned project leaders will keep an eagle eye on resources and reporting, ensuring that our experts within each discipline work seamlessly together in collaboration with your team to achieve the best results on time and within budget.

Some of our key services within drug development are:

  • Regulatory strategies
  • Planning, preparation of Scientific Advice meetings (national authorities throughout Europe, EMA and FDA)
  • Toxicology/non-clinical experts and development strategies
  • Pharmacokinetics, drug metabolism and drug interactions experts and development strategies
  • Advice on formulation development and CMC
  • Clinical pharmacology experts and development strategies
  • Clinical trial design including statistics
We work seamlessly together to help you bring new drugs to those who need them