Pharmacovigilance

Safety surveillance of medical products is essential and business critical. In recent years regulatory authorities in the European Union have increased their focus on drug safety, resulting in more complex and extensive legislation.

A+ Science’s pharmacovigilance team has both the critical knowledge of the regulatory requirements and the medical expertise to offer pharmacovigilance services during clinical development and after marketing authorization.

We offer our services to pharmaceutical companies, generics companies, biotech companies, medical device companies, Clinical Research Organisations (CROs) and to individual researchers.

What we do

• Pharmacovigilance Plans
• Risk Management Plans (RMP)
• 24-7 pharmacovigilance support
• A validated pharmacovigilance database (21 CFR part 11 compliant)
• SAE/AE/ADR handling (collection, database entry and evaluation)
• Weekly literature search
• EudraVigilance registration
• Expedited reporting, including reporting to EudraVigilance
• Signal detection
• Medical analysis
• Periodic Safety Update Reports (PSUR)
• Annual Safety Update Reports (ASUR)
• Benefi t/risk assessment
• Pharmacovigilance training to staff (including sales representatives)
• Standard Operating Procedures (SOPs)
• Pharmacovigilance audits
• Safety Studies/Post-Authorization Surveillance Studies (PASS)
• Outsourcing of pharmacovigilance personnel

We customize pharmacovigilance solutions to meet your needs.