Get the Customized GxP Compliance Strategy You Need In the Pharmaceutical, Medical and Dental Industries
GxP-Compliance Consulting helps ensure your compliance provisioning through a nimble, one-team approach made up of professors, doctors, pharmacists, lawyers and IT expertise with over 28 years’ experience in the Life Science industry.
Our specialized teams are lean, effective, fast, and able to tackle your most challenging compliance issues in an efficient and timely manner by unifying Quality Assurance, Technology and Legal departments into a cohesive unit. We often are called in when the most critical of resources and experience is desired in order to both consult the consultant and watch the watchmen within the area of Quality Assurance and Information Security in the most effective and at the same time discreet manner.
Services
- Quality Management support in all aspects of GxP compliance
- Setup and accompaniment of Validation/Quality Assurance strategies
- Validation of production facilities and related laboratories
- Validation services for a wide range of computer systems (ERP, non-ERP Systems and Embedded Systems)
- Training in work relevant to compliance (e.g. audits, software development life-cycle, information security)
- Project Management for GxP-relevant projects
- Provisions to set up custom audit programs
- Information Security Architecture Design
- Information Security, Quality Management, and Information Technology Integration
- Cyber Security Design and Integration
- Data Exfiltration Policy and Design
- Penetration testing and Vulnerability Assessment Support
- Governance and Enterprise Security Integration
- Network and Infrastructure Security Design
483
EU/EC
ICH
FDA
Comply with Regulatory Authorities
From a compliance perspective, one size does not fit all, especially in a globalized world. That’s why we take pride in meeting your select needs, working worldwide in 28 countries and in 12 languages.
No matter where you’re located, GxP-CC will work alongside your team to help you overcome the challenges of meeting compliance regulations set by national and international regulatory authorities. You can count on the company that is based on Trust, Transparency, Protection and Care.