SK Consulting - Sylvia Kranich

SK Consulting is an independent consultancy providing Quality Management, GCP and GPvP services for Pharmaceutical, Biotech and Medical Device Companies assuring compliance with international/national applicable regulations and standards and protecting patient’s safety and rights.

Sylvia Kranich (SK Consulting) has over 22 years within Quality Assurance and Quality Management. Since approximately 10 years she extended her expertise to Pharmacovigilance services with respect to Quality Management and Auditing. She provides her services in Europe, USA and Asia/Pacific.

Services

Services include but are not limited to:

-          Quality Assurance Auditing (Investigational Site Audits, Vendor Audits, Sponsor Audits)

-          For Cause Audits

-          Document Audits

-          Data Management Audits

-          System/Process Audits

-          Pharmacovigilance Audits (License Partners, Affiliates, Vendors, Distributors)

-          Quality Assessments of systems and processes

-          Training (developed according to client needs)

-          Evaluation, guidance and advice in establishing a Quality Management System

-          Support in Risk Assessment, Evaluation and Adaptation

-          Inspection Readiness and Consultation

-          Audit Coaching

 

Availability for Work

Worldwide

Areas of Expertise

GCP, GPvP

Contact Details

SK Consulting

Sylvia Kranich

Kienberghof 9, 4450 Sissach, Switzerland

Email: skconsulting@bluewin.ch

Webpage: www.skconsulting.eu

Telephone: +41 (0) 61 973 05 65

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