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 Process/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 collaborate with my clients in working out new concepts and/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. A risk-based approach is the basis for the consultation. Together with the client meaningful strategies, time schedules and action plans can be initiated and implemented. Close cooperation therefore is the basis for a successful collaboration and being applied since the beginning of the consultancy.
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 part of my services as well as coaching/training of assigned people in this function. I am one of the speakers in the PV QMS Training Module of the Pharmig Academy. Audits are always including aspects of patients safety, therefore my clients are informed about possible issues related to PV (included in the reporting system of SK Consulting). Auditing of interventional/non-interventional, academic clinical trials and other types of studies (PASS) is part of the PV Activities.