Welcome to SK Consulting
Since 1984 I am working in various Research & Development areas (i.e. PK/PD Research Laboratory, Central Clinical Safety Laboratory, Research&Development of Dialyse Membranse, CRO). SK Consulting was founded in 1995 and since that time I am providing advice and consultation in establishing Quality Management Systems for small and medium size companies (SMEs), performing a full range of GXP QA System Audits with focus on GCP, GPvP and GCLP on an international basis, evaluating/assessing Phase I Units, providing client oriented Training (in-house class-room training or individual based Training (coaching in QMS/QA)) and assessing applicable systems within the companies, identifying the risks and gaps and work out new concepts or improving available concepts. All type of audits are process oriented and include overlapping areas/functions and therefore including aspects of other GXP standards (i.e. GMP, GLP).
All services offered by SK Consulting are conducted according to national/international applicable regulatory requirements, ICH GCP and Guidelines provided by EMA, MHRA, FDA and other applicable regulatory authorities as well as applicable SOPs, project specific instructions and contractual frameworks. Overall I am advicing my clients for reasonable and meaningful approaches to meet regulatory requirements and international/national standards. Together with the client in a close cooperation, strategies, time schedules and action plans are worked out.
Since 2004, Pharmacovigilance Systems and legislation became a dominant factor in my consultational work. I am performing assessments/reviews of current Pharmacovigilance Systems within SMEs and/or providing support in establishing a functioning Quality Management System within PV. Pre-inspection Audits (Mock Inspections), Affiliate / Parnter Audits with respect to PV Activities are performed by myself and/or I am coaching/training assigned people in this function. Training Courses can be held externally or internally, whereby I am managing the entire logistics if requested. I am one of the speakers in the PV QMS Training Module of the Pharmig Academy and also presenting occassionally on Conferences with respect to Quality Management Systems and Risk Management. The assessment of the PV System includes current systems used by the client as well as any possible interaction with vendors involved in PV. Auditing of interventional/non-interventional, academic clinical trials and other types of studies (PASS) is part of the PV Activities.