About Steen Ottosen ApS

Full package of PV Services

While we are focused on QPPV and PSMF support we can help with all aspects of drug safety during clinical development as well as from the time you submit the market autorisation application and after the drug is approved.

Qualified Person for Pharmacovigilance

The Qualified Person for Pharmacovigilance is an individual personally responsible for a Pharmaceutical company/Marketing Authorisation Holders …..

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Pharmacovigilance System Master File

The regulations for the European Union has a requirement for a Marketing Authorisation holder to maintain a document with all information relevant for the safety of a marketed …..

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Regulatory compliance
   

Regulations and practices are constantly changing in Europe, US. Australia, Japan, China and the rest of the world. We are following the trends and adapt procedures and reporting accordingly.

Standard Operating Procedures

The drug safety/pharmacovigilance function of a Pharmaceutical companies are required to keep a quality management system in place. A central part for the quality management system is written policies, procedures and detailed work instructions as well as documentation for review and training in these instructions by all relevant staff in the company, suppliers, contractors and partners. 

Signal Detection

Data received from non interventional studies, clinical trials and post market experiences are monitored to ensure timely identification of new potential safety issues with your products. Fast identification and verification of signals is essential to keep patients and the product safe and for you to know before the regulatory agencies start asking the critical questions.

Living it up in Copenhagen, Denmark.