PSUR writing

Concentrate on your core business

Keep your in-house resources free and benefit from our experience in the field of pharmacovigilance for PSUR writing. We also support you in the renewal of marketing authorisation with an up-to-date report on the risk-benefit profile of your product.

This PSUR bears your signature

Within the scope of the statutory provisions, you determine the form of your PSUR. We adopt your templates and prepare the documents according to your guidelines with regard to form. Medical advisors and drug safety specialists with many years of experience stay in contact with you, thus guaranteeing tailored safety reports. If required, we can also utilise our quality-assured templates for PSUR writing.

Flexible data preparation

Pass on your existing data to us. No matter whether it is ADR reports, clinical trials or core data sheets: the material you supply will be included in the PSUR according to the requirements of the supervisory authorities. You can also benefit from our extensive experience when conducting research and evaluations on case reports and relevant clinical trials in scientific publications.

Expert risk analysis

In consultation with you, our experienced team of medical advisors assesses the risk-benefit profile of your product and discusses the results with your own experts. For quality assurance the documents we prepare are subjected to a standardised quality control procedure.

PSUR writing and more

Our services range from the professional proof-reading of your own safety reports and the writing of addendum or bridging reports to the complete handling of a PSUR project. We prepare expert statements for marketing authorisation renewal and submit them to the supervisory authorities. You are flexible in your choice of services, ensuring that you receive a product which is tailored to your individual needs.