Our Services
Pharmacovigilance (human and veterinary)
Pharmacovigilance (human and veterinary)
Pharmacovigilance (human and veterinary)
· Pharmacovigilance system set-up
· UK National Contact Person (UK NCP)
· Pharmacovigilance System Master File (PSMF)
· Aggregate reports (PSURs, PBRERs, PADER, DSURs)
· Safety database support (implementation, migrations, upgrades, user manuals)
· Safety Data Exchange Agreements (SDEAs)
· Process evaluation, improvement and gap analysis
· Inspection readiness: support pre, during and post inspection
· Training
Quality
Pharmacovigilance (human and veterinary)
Pharmacovigilance (human and veterinary)
· GVP and GCP safety auditing (including Medical Information service providers)
· Gap analysis
· Controlled document preparation: Standard Operating Procedures (SOPs), Working Instructions and guidance documents
· Inspection readiness: support pre, during and post inspection
· Training
Medical Information
Pharmacovigilance (human and veterinary)
Medical Information
· Medical Information service set up
· Process development and maintenance
· Standard response development and maintenance
· Inspection readiness: support pre, during and post inspection
· Training