GCPs (Good Clinical Practices):
Working in Biomedical research is a big challenge to be heavily supported by an updated, audited and well established quality system. In QualitecFarma we have a proof and qualified GCP system as a result of a well structured Quality Dept leaded by deep experienced experts. We are more than happy to offer audit slots to our clients so that we can become your preferencial provider. In addition we are proud to offer site quality audits to your Clinical Trials through our experienced team and a solid and updated SOPs
GMP (Good Manufacturing Practices):
One of the main characteristics’ of a medicine is quality of manufacturing. In QualitecFarma we have been working with quality systems since the beginning, and our experts in GMPs are more than 25 years of experience auditing and adapting manufacturing quality systems to Eu or FDA GMPs. From an initial pre audit to a full project to implant of a GMP at a medicines manufacturing facility, including SOPs, processes, staff training and Company quality policies to change philosophy QualitecFarma is qualified to lead the project to an international success.
ISO and General Quality:
the Pharmaceutical Industry is one of the most strict and rigorously regulated field. We know it but we are willing to go a step forward. Therefore all the company business units are ISO9001/2015 certified from Regulatory, to Pharmacovigilance and as a master commitment with support and service to our sponsors and clients GCP system is also in compliance. Our commitment with quality means that our believe is full compliance with quality as a starting point to work with our clients.