REACH UP srl offers assistance to pharma companies from the development of drugs still their registration according the law. The presence of pharmacologically active substances should be limited to a level toxicologically considered safe for all those who will be exposed (operators / end users).
The protection of workers requires the determination of occupational exposure level (OEL) and the protection of enduser requires the derermination of the permitted daily exposure (PDE) (according GL: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/11/WC500177735.pdf).
Our services about pharma include:
- Assistance on regulatory obbigations
- Reviewing and/or revising of toxicological available data during screening phase for new molecules and derivates
- Planning of dossier compilation strategy
- Use of no testing methods (NTMs: QSARs, Read-Across, grouping..)
- Proposal and/or managment of new studies
- Human health risk assessment
- Determination of the permitted daily exposure (PDE)
- Authorization process
- Creation of the dossier
This expertise is available to issue specific customer requirements and our team work judgement will offer the best available solutions.