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PHARMA

 

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.