Quality & Compliance
Quality & Compliance is an integral part of the Life Science industry and how KPC operates. As an ISO9001:2015 accredited organisation we understand how to provide integrated and risk-based solutions to regulatory and quality compliance challenges.
Our Quality Management system helps us to focus on excellence in customer satisfaction.
Our team at KPC can provide expertise in the following areas:
- Quality Systems (ICH Q10 & ISO9001:2015)
- FDA, EMA (ICH), PIC’s Regulatory guidance for Pharmaceutical and Biotechnology projects.
- QA/QC Resource Planning and Development
- Vendor/Supplier Auditing
- QA Compliance support services
- Assessments of adherence to compliance to global standards/site procedures
- Deviation Resolution & CAPA Management
- GMP Training
- Quality Risk Management (ICH Q9)
- Electronic Quality Systems
- Regulatory Submission
- Development of a Quality Culture
Benefits of Implementing a Quality Solution with KPC International:
- Extensive experience in dealing with a wide range of quality support systems and developing a quality culture
- Our consultants work closely with the regulators
- Our in-depth quality and compliance knowledge and expertise
- Our risk based lean thinking.