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)
Products
Life Science
Validation and compliance services for computerized systems supporting Good Distribution Practices (GDP) in pharmaceutical and life sciences supply chains.
Life Science Data Integrity
Consulting and support services for building strong data integrity programs and ensuring compliance in the life science industry.
Life Sciences Compliance & Validation Services
Consulting and validation services supporting the full lifecycle of computerized systems, compliance, and operational efficiency for life sciences organizations.
Digital Compliance and Protection Services
Comprehensive life sciences digital compliance, computer system validation, and data protection consulting services designed to align systems with GxP regulatory requirements and ensure secure data handling.
AI/ML Validation Services
Validation services that help life science companies navigate regulatory requirements for artificial intelligence and machine learning technologies.
Validate AI/ML Systems – GxP AI Validation
Practical, risk-based validation strategies for AI and ML applications ensuring systems meet compliance requirements without slowing innovation.
Life Science
Validation and compliance services for computerized systems supporting Good Distribution Practices (GDP) in pharmaceutical and life sciences supply chains.
Life Science Data Integrity
Consulting and support services for building strong data integrity programs and ensuring compliance in the life science industry.
Life Sciences Compliance & Validation Services
Consulting and validation services supporting the full lifecycle of computerized systems, compliance, and operational efficiency for life sciences organizations.
Digital Compliance and Protection Services
Comprehensive life sciences digital compliance, computer system validation, and data protection consulting services designed to align systems with GxP regulatory requirements and ensure secure data handling.
AI/ML Validation Services
Validation services that help life science companies navigate regulatory requirements for artificial intelligence and machine learning technologies.
Validate AI/ML Systems – GxP AI Validation
Practical, risk-based validation strategies for AI and ML applications ensuring systems meet compliance requirements without slowing innovation.
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