Non-Clinical Development

TMC Pharma Services non clinical and manufacturing support

Non-clinical, manufacturing and quality

Non-clinical services

  • Highly experienced non-clinical experts to review data for regulatory acceptability and advise on development strategy
  • Location of, and liaison with, third-party toxicology providers
  • Liaison with academic units to obtain pharmacodynamic data
  • Well-established contacts with academic units for preclinical anti-infective products evaluation

Manufacturing and quality services

  • Pragmatic and experienced specialist QPs (qualified persons) to
    • provide EU QP certification for clinical trials, and
    • review data for regulatory acceptability, compile IMPDs and advise on development strategy
    • auditing of manufacturing sites for compliance with GMP
  • Location of high-quality GMP units, particularly those able to produce special batch sizes
  • Liaison with clinical trials supplies management units, importers and distributors
  • Management of import and QP release of investigational and marketed drugs in the EU