Services PHARMA
Drug development program
ECsc provides following services
- Non-clinical regulatory strategy
- Designing drug developmental plan, FIM (Fast into man)
- Regulatory contacts with FDA / EMEA / MHW
- Toxicology and pharmacology testing strategy and test plans
- Evaluation of documentation (quality, efficacy, safety)
- Writing of individual modules or parts of CTD or other documentation
- Arrangement of study placement and performance: QSAR, in vivo and in vitro toxicity, environmental toxicity, safety pharmacology
- Writing of investigator´s brochure
- Environmental risk assessment
