Our Service
This is a summary of our services. Please Contact us if you want to discuss any details
Phamacovigilance
UK Qualified Person for Pharmacovigilance (QPPV)
UK National Contact Person for Pharmacovigilance (NCPP)
Quality
· Auditing (including Medical Information service providers)
· Inspection readiness: support pre, during and post inspection
· Controlled document preparation: Standard Operating Procedures (SOPs), Working Instructions and guidance documents
· Training
Medical Information
· Medical Information service set up
· Process development and maintenance
· Standard response development and maintenance
· Training
Pharmacovigilance (human and veterinary)
· Pharmacovigilance system set-up
· UK Qualified Person for Pharmacovigilance (UK QPPV)
· UK National Contact Person for Pharmacovigilance (UK NCPP)
· Pharmacovigilance System Master File (PSMF)
· Detailed Description of the Pharmacovigilance System (DDPS; veterinary)
· 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
· Training
FAQ
This is a summary of our main services. Please Contact us if you want to discuss any other requirements you have.