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Consultancy

With inspiring thought-leaders, we advise Life Science organizations on state-of-art (and sometimes disruptive) principles of lean recording of the proof medicinal product’s quality, safety and efficacy and the exchange of this information and knowledge to Health Authorities.

We provide regulatory consultancy on reducing time-to-submission by aligning people, processes and tools supporting scientific/strategic and operational aspects of drug development.

A scientific approach and engagement of people in lean business processes result in data, documents and dossiers that ensure the highest possible quality of regulatory applications, with an ultimate aim of providing benefits to applicant, agency and patients.

Our areas of expertise are: