SK Consulting Sylvia Kranich

The core activity of SK Consulting is the consulting and implementation of quality management systems, audits and training for small and medium-sized enterprises (SMEs) in the pharmaceutical industry, particularly in the area of clinical research and pharmacovigilance. The services include: Consulting on the introduction of quality management systems, Conducting audits (GXP, GCP, GPvP, GCLP) and risk assessments, Training and coaching in quality management and pharmacovigilance, Evaluation and improvement of pharmacovigilance systems, Conducting pre-inspection audits and affiliate partner audits. The activities are carried out in accordance with national and international regulatory requirements, ICH-GCP and guidelines from EMA, MHRA, FDA and other authorities.