Other Services

Services related with specific activities of Pharmacovigilance and Quality Assurance. Compliance with applicable regulations in all processes will be verified, as well as the corresponding Standard Operation Procedures (SOPs) and the International Conference on Harmonization (ICH) Guidelines.

Quality Assurance

– Writing manuals and guidelines
– Writing SOPs
– Audits
– Audit reports
– Corrective actions and preventive actions
– ICH Standards and guidelines
– Good Clinical Practice (GCP)

Pharmacovigilance

– Management and control of Adverse Events / suspected Adverse Drug Reactions
– Adverse Events / Drug Adverse Reactions expedited Reports
– Periodic Bibliographic search
– Periodic Safety Update Reports (PSURs)
– Expert Reports
– Drug Benefit / Risk analysis
– Post-marketing study reports
– Writing SOPs
– ICH Standards and guidelines