DADA Consultancy carries out database and literature searches for carcinogenicity and bacterial mutagenicity data, computational toxicology assessment by two complimentary (Q)SAR prediction methodologies (one expert-rule and one statistical-based) for bacterial mutagenicity and expert analysis including read-across all according ICH-M7.
DADA Consultancy carries out the Phase 1 ERA risk assessment and Phase 1 PBT (Persistent, Bioaccumulative and Toxic) risk assessment according current guidelines and helps you avoid costly Phase 2 ERA risk assessment.
DADA Consultancy carries out the evaluation of all available pharmacological and toxicological data, and in concordance with ICH guidelines, constitutes a permitted daily exposure (PDE) report including a clear scientific rationale.
Derived threshold values can be used as a risk identification tool and can also be used to justify carry over limits used in cleaning validation.
DADA has experience in planning and applying for Early Access Program authorisations in the BeNeLux. These programs ensure access of clinical trial participants to their successful treatment after finalisation of the clinical trial until marketing of the drug, the compassionate availability of the medicine after MA application but before commercialisation and supply on a per-named-patient basis of medicines without an MA in the concerned countries.
DADA Consultancy is a highly specialised and independent consultancy agency in international regulatory affairs of human and veterinary medicinal products.
Our customer support is available from 9am to 5pm: +31 24 373 03 09
Monday-Friday: 9am to 5pm
Saturday: Closed
Sunday: Closed