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

One Stop Shop

At PharSafer®, we offer a breadth of services for clients around the world. View our full shopping list here to select the services you need to achieve your compliancy goals.

FIND OUT MORE HERE
Services

We’re with you at every step of the journey!

Services

We’re with you at every step of the journey!

SUBMIT RFP