Bringing product quality in line with patient safety is foremost the key element when providing support to any of our life science partners. The ever-changing and challenging environment brought to us by the performance of our systems and resources, in combination with the regulatory environment, creates an additional layer of complexity.
Our consultants with a heart for quality assurance can perform within the entire span of quality management from the design and set-up of a quality management system, fact-based risk management assessments, product release and distribution (QP & amp; RP activities), deviation handling and deep-dive root cause analyses, and (mock)audits.
Our expertise in quality management entails the following:
- Knowledge and interpretation of local and international regulations for human and veterinary medicinal products, blood and biological products, advanced therapy medicinal products (ATMP), medical devices (MD), companion diagnostics (CD), in vitro diagnostics (IVD) and medicinal substance or active pharmaceutical ingredients (APIs), excipients and adjuvants
- Strategy and implementation of qualitative risk management (ICH Q9)
- Quality system documentation on the effectiveness of the organisation and design (ICH Q10)
- Quality Assurance Management and Training
- Quality training (GLP, GMP, GdocP, GDP)
- Implementation and training of ICH guidelines
- Incident investigation with substantiated root cause analyses (RCA), corrective and preventive actions (CAPA) and operational quality management in production and laboratory environment
- Assessment and management of suppliers and contracted manufacturers
- Development of test methods, operational support, trend monitoring and quality assessment
- Pre- and post-audit support
- Internal audit programs for GMP, GDP and ISO -13485
- Applying local and international systems, including FDA, ISO, Brazilian, Chinese and other international standards
- GAP assessments and implementation of required programs
- Data integrity (DI) assessment of production and laboratory processes
