Skip to main content

Further Indications

Further Indications of SCRATCH Pharmacovigilance GmbH

scratch is also licensed for the following additional indications:

  • weitere-anwendungsgebieteAvailability / management of an inspected safety database that can report electronically – if needed, we can also enter your cases into your database
  • Management of Adverse Drug Reaction (ADR) case reports, including follow up and regulatory reporting – for both Serious Adverse Events from clinical trials as well as cases from Postmarketing. This also includes the increasingly important area of non ADR safety information, e.g pregnancies, drug misuse, maladministrations, etc.
  • Managing Drug Safety Monitoring Boards (DSMBs)
  • Creation and maintenance of the Pharmacovigilance System Master File (PSMF)
  • Interface management technical complaints / pharmacovigilance (PV)
  • Replies to PV related requests and measures by regulators, e.g. EU Referrals or recalls
  • PV Due Diligence, e.g. before inlicensing or mergers
  • Interim PV Management or operational support
  • Pharmacovigilance training (read more…) 
  • Risk Simulation
  • Management Coaching / Strategic PV Consultancy
This is just a part of our portfolio. In case of additional questions or special issues, where we might be of help, give us a call. Or send us an e-mail.