Pharmaceuticals
Our team of pharmaceutical experts at ECT compiles dossiers for the environmental risk assessment of medicines: for medicinal products for human use according to the recently revised guideline EMEA/CHMP/SWP/4447/00 Rev. 1, and for veterinary medicinal products according to EMA/CVMP/VICH guidance.
We are familiar with all parts and tiers of the environmental risk assessment of pharmaceuticals. Based on our experience in national and international research projects (e.g. iPiE and PREMIER), we can provide scientific expert advice particularly in complex cases, higher tier requirements and risk management options.
ECT supports your company during the pharmaceutical registration procedure by providing the following services:
- Identification of information requirements and data gaps
- Data mining and literature search
- Placing, performing and monitoring of required fate and effect studies according to Good Laboratory Practice (GLP)
- Conducting Phase I and II of the environmental risk assessment for human as well as veterinary pharmaceuticals
- Dossier preparation (CTD Module 1.6)
- Providing expert opinion reports on specific questions regarding effects, exposure and risk management
- Communication with the competent authorities
