Planning and monitoring of preclinical studies

Critical review of study protocols and monitoring of studies placed with CROs are indispensable for achieving a valid outcome of experimental studies. We evaluate and accompany preclinical investigations critically and independently.

 

Preclinical dossiers

Acquisition of investors as well as in- or out-licensing of drugs in early development requires thorough and competent review of the data. This is all the more true when dossiers are prepared for submission to regulatory agencies. We review the data for completeness, technical competence and scientific content. Dossiers such as Investigator’s Brochures, CTDs and IMPDs are assembled and reviewed in a critical and independent manner.

 

Regulatory consulting and guidance at regulatory submission

Personal work experience and insight into the German regulatory agency BfArM facilitate the approach to and cooperation with the authorities. This can especially help small pharmaceutical companies that possess limited expertise with regulatory authorities. We have experiences with the regulatory authorities of the USA and have supported successful completion of national, European and international admission procedures. Furthermore, we support companies dealing with complicated regulatory challenges.