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  • PIL READABILITY TESTING
  • SCIENTIFIC AND REGULATORY CONSULTING
  • PHARMACEUTICAL SPECIALISED TRANSLATIONS
  • PHARMACOVIGILANCE SERVICES
  • WRITING OF ALL MODULES OF AUTHORISATION DOSSIER
  • CTD AND eCTD SUBMISSION AND COORDINATION OF THE REGULATORY PROCEDURES
  • QUALIFIED PERSON ACTIVITY FOR BATCH RELEASE
  • QUALITY TESTING OF MEDICINES ON EEA TERITORY
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QUALIFIED PERSON ACTIVITY FOR BATCH RELEASE

 

EU legislation requires medicinal products to be certified as complying with various authorisations, national legislation and GMP. The legislation assigns personal responsibility for these activities to a ‘Qualified Person’ and requires that every manufacturing site (including those manufacturing investigational medicinal products) employs the services of such a person. Under the permanent provisions of the EU legislation (2001/83/EC) educational and experience criteria need to be fulfilled. In the case of products imported from a third country, RUAL Farm can provide the Qualified Person services. If required, our certified QP specialists will assume responsibility and act on behalf of the client as Qualified Persons for Batch Release (QP).

 

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