Neuchâtel, Switzerland
20 years of experience in quality assurance within the pharmaceutical industry (GCP/GMP/GLP/GVP). 15 years of auditing experience in GCP. Why do clients hire ObelysQ? - For our deep understanding of the regulatory requirements and inspectors’ expectations - For our thorough analysis of their organizations and identification of areas for improvements - For our pragmatic approach to identify, develop and implement efficient solutions - For our flexibility in accommodating their needs
Business development and customer support Management of a team of consultants worldwide Consulting services provided: • GCP consulting • GCP audit conduct (site, vendor, system, affiliate) (remote/onsite) • Health Authority Inspection preparation and support • SOP development • Gap analysis • Tailored training sessions
Perform GCP audits of clinical sites, vendors, and affiliates Perform internal audits Facilitate GCP training Host/support regulatory authorities inspections (FDA, Health Canada, EMA, MHRA, BfARM, ALIMS, Infarmed, TFDA, SFDA, AGES, ANSM, AFMPS, CFDA, SwissMedic, URPL ) Act as Program Lead for two clinical development programs Act as Inspection lead for Reblozyl submission in EU and US (2 sponsor/monitor inspections, 5 site inspections) Act as GCP contact person for the Medical Affairs sponsored trials Act as GCP contact for data privacy issues, liaising with the legal department Act as GCP consultant for process improvement initiatives Act as GCP consultant for the clinical operations department Responsible for the GCP content of Pharmacovigilance System Master File
Support to Clinical, Pharmacovigilance and Medical activities. Audit of clinical sites, vendor qualification and internal audits.
Teaching 'Requirements for Sterile production' for the continuing education program.