Pharma Consulting Aachen is a group of clinical and preclinical experts around Prof. Konrad Heintze, located in Aachen and Berlin, Germany. The team consists of specialists in clinical research, pharmacology, toxicology, pharmaceutical quality, and pharmacokinetics. It benefits from long-standing experience in the pharmaceutical industry and as independent experts in pharma and biotech consulting.
Pharma Consulting Aachen specializes in designing drug development strategies and devising, accompanying, and evaluating clinical and preclinical investigations. The group prepares and reviews pharmacological, toxicological, and pharmacokinetic expert reports as well as documents on pharmaceutical quality. Corresponding literature searches are provided 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 preparation, review, and evaluation of complete documentations (CTD) for pharmaceutical approval procedures. If needed, clinical documentations are prepared in cooperation with external partners. The group offers regulatory consulting and guidance at regulatory submissions. Our group profits from first-hand experience within the German regulatory agency (BfArM), and cooperates with the agency regarding assessment reports. We have supported successful national, European and international admission procedures.