Involvement in 1st Covid Vaccine Development Programme
750,000+
Cases Processed
Cases Processed
6,000+
PSURs/DSURs/PBRERs and RMPs Written/Processed
PSURs/DSURs/PBRERs and RMPs Written/Processed
Specialists in global clinical and post marketing drug safety
As specialists in global clinical and post marketing drug safety, we consider Safety to be the centrepiece of our services and the foundation of our business.
From routine pharmacovigilance services, such as the individual case processing of adverse reactions (ICSRs); comprehensive literature searching; signal detection; periodic report writing; risk management/minimisation and medical device safety, all the way through to more bespoke service offerings, such as vaccines; biologics; cosmetics; advanced therapy products; drug-device combinations and many other consultancy services, PharSafer® will advise and guide you on your way to meeting your regulatory compliance obligations.
Key Pharmacovigilance Services Offered:
- Full Manual Case Processing of Adverse Reactions (ICSRs/SUSARs/SAEs);
- Pharmacovigilance Project Management;
- Comprehensive Literature Searching;
- EU QPPV PV, Local QPs;
- Signal Detection, Trend Analysis, Benefit-Risk determinations;
- Risk Management Plans (RMPs)/Risk Evaluation and Mitigation Strategies – Design and Maintenance;
- Periodic Report Writing (PBRERs, DSURs, PADERs; INDs; PIFs);
- Clinical Trial Safety Documentation (IBs, CRFs, Protocol reviews, DCSI etc…);
- Medical Device Safety;
- Global Expedited Reporting submission and supervision;
- Safety Labelling Management (DCSI/CCSI/Local labelling updates);
- Up to date EU PSMF & Local PSMFs;
- Covering Drugs, Vaccines, Cosmetics, Advanced Therapies, Drug-Device Combinations and more
