๐ฌ Supportย during audits, inspections, QA/QC meetings and clinical trials for pharmaceutical companies and CROs.
๐ฏ Technical terminology, precision and confidentiality.
๐งฌ Interpretation services for GMP audits (AIFA-EMA-FDA)
- ๐ Audit & GMP inspections: inspections, interviews, walk-throughs and follow-ups.
- ๐๏ธ Meeting QA/QC: translation of medical records, deviations, SOPs, batch record review.
- ๐ฅ Clinical trials: investigator/sponsor/CRO meetings, pharmacovigilance
๐งญ Mode
- ๐ค Remote is not suitable for inspections.
๐ Languages
- ๐ฎ๐น โ๏ธ ๐ฌ๐ง English โ Italian
- ๐ง๐ท โ๏ธ ๐ฎ๐น Brazilian Portuguese โ Italian
- ๐ง๐ท โ๏ธ ๐ฌ๐ง Brazilian Portuguese โ English
- ๐ซ๐ท โ๏ธ ๐ฎ๐น French โ Italian
- ๐ซ๐ท โ๏ธ ๐ฌ๐ง French โ English
๐ก Why choose this service
- ๐ซ Experience on AIFA, EMA, FDA audits in Italy, Europe, Africa and Brazil.
- ๐ Alignment with SOP and corporate lexicon.
- โฑ๏ธ Quick availability, even on emergencies.
- ๐งพ Briefing pre-audit e debrief post-audit.
- ๐ Confidentiality guaranteed, operation with NDA on request.
๐ Is it available in presence and remotely?
Yes. In attendance in the indicated regions. Remote does not fit and is not used for inspections
๐ Is it possible to sign an NDA?
Yes, confidentiality is an integral part of the service and the NDA is available on request.
๐จ How to request availability and a quote?
Fill in the form below or use direct contact. Quick response with technical and economic proposal.
