GxP-CC
GxP-CC helps pharmaceutical and health sciences companies comply with complex and evolving regulations and quality standards. They provide highly customized and collaborative compliance solutions, enabling clients to move projects forward with confidence. Their mission is to make sustainable life sciences compliance a competitive edge, leveraging innovative technologies and risk-based approaches to improve efficiency, address risks early, and support staff training. GxP-CC emphasizes corporate responsibility, diversity, and sustainable practices, including green initiatives and community support.
Industries
Nr. of Employees
small (1-50)
GxP-CC
Services
Assessments and remediation plans to ensure data reliability across discovery, development and commercial operations.
Technical and organizational controls to mitigate digital and cybersecurity risk while meeting regulatory requirements.
Translate regulatory requirements into procedures, controls and quality systems to operationalize compliance.
Validation lifecycle services for computerized systems including planning, testing, verification and UAT for regulated environments.
Assessments and remediation plans to ensure data reliability across discovery, development and commercial operations.
Technical and organizational controls to mitigate digital and cybersecurity risk while meeting regulatory requirements.
Translate regulatory requirements into procedures, controls and quality systems to operationalize compliance.
Validation lifecycle services for computerized systems including planning, testing, verification and UAT for regulated environments.
Expertise Areas
- Data integrity and governance
- Computerized system validation (CSV)
- Digital compliance and cybersecurity for life sciences
- Quality management and GMP/GCP compliance
Key Technologies
- Electronic Data Capture (EDC)
- Clinical Trial Management Systems (CTMS)
- Interactive Response Technology (IRT)
- Trial Master File (TMF) systems