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About Agnes Gorecka
This author has yet to write their bio.Meanwhile lets just say that we are proud Agnes Gorecka contributed a whooping 6 entries.
Entries by Agnes Gorecka
The EU regulates advertising of pharmaceutical products on a member state level. This requires expertise on a member state level. DADA is an established service provider in the field of pharmaceutical advertising. Our dedicated and qualified team supports you in obtaining high quality and compliant pharmaceutical advertising. DADA provides compliance review for the full spectrum […]
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 […]
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 […]
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