Pharma Consulting Aachen is a group of preclinical experts around Prof. Konrad Heintze, located in Aachen and Berlin, Germany. The team consists of specialists in pharmacology, toxicology, pharmaceutical quality, and pharmacokinetics, and benefits from long-standing experiences in the pharmaceutical industry and as independent experts in pharma consulting and biotech consulting.

Pharma Consulting Aachen is specialized in compiling drug development strategies and in evaluating and accompanying preclinical investigations. The group prepares and reviews pharmacological, toxicological, and pharmacokinetic expert reports as well as documents on pharmaceutical quality and provides corresponding literature searches by request. Besides chemometric and multivariate analyses for drug substance and drug product development (DOE, PAT and QbD), expert reports such as QOS, QES, IB, and IMPD as well as environmental risk assessment (ERA) reports are compiled, evaluated and reviewed by our team.

Pharma Consulting Aachen is experienced in reviewing, evaluating and preparing of complete documentations (CTD) for pharmaceutical approval procedures. If needed, clinical documentations are accomplished in cooperation with external partners. The group offers regulatory consulting and guidance at regulatory submission.
Our group profits from first-hand experience within the German regulatory agency, BfArM, and cooperates with the agency regarding assessment reports. We support successful completion of national, European and international admission procedures.