Pharma Consulting Aachen is specialized in finding answers

to your questions and developing solutions for your problems. Our service includes

• Writing, reviewing, and editing of preclinical reports
• Writing of publications of clinical and preclinical studies, writing of reviews
• preparation and evaluation of pharmacological, toxicological, and pharmacokinetic expert reports
• documents on pharmaceutical quality
• we provide and evaluate independent expert reports
• Environmental risk assessment (ERA) reports, review of study designs, analysing data and writing the corresponding reports
• Planning and monitoring of preclinical studies
• we review the data of your drug for completeness, technical competence and scientific content. Dossiers are assembled, including Investigator’s Brochures, CTDs and IMPDs, in a critical and independent manner
• Regulatory consulting and guidance at regulatory submission
• Advice on strategic development
• Drug substance analyses and drug product development
• Where questions arise that are not covered by the group´s expertise, Pharma Consulting Aachen is supported by a network of independent specialists covering each topic
• Experience with in silico prediction techniques; impurity qualification