comes compliance services  is an independent, highly experienced, and premier consulting company specializing in simplifying and streamlining EMA, FDA, ICH, GHTF quality systems, and fulfilling validation and regulatory compliance requirements. At comes compliance services (CCS), we strongly believe that quality and compliance management will drive continuous improvement and performance optimization. We utilize a more pro-active and risk-based approach to quality assurance and validation backed by proven expertise and electronic tools from our partners. We focus on value-added project, process and risk management to achieve regulatory compliance and inspection readiness.

Minimize risks, lower costs, and speed up your time to market with strategies, policies, and controls that improve your compliance and contribute to your bottom line. Our services are backed up by theorectical resources and thorough regulatory knowledge. They will be demonstrated through practical examples and explained and implemented by experienced professionals.

The following services and products are available to GMP, GLP, GCP and medical device regulated companies and suppliers:

• Quality Management Services (ISO 9001; ISO 13485; ICH Q10; APIC/CEFIC; etc.)
• IT Project Management Services (Project Management Body of Knowledge)
• Comprehensive and risk-based qualification / validation concepts and services (ISPE GAMP 5)
• Validation Tools for Requirements, Project, Audit, and Test Management
• IT Network Qualification (ITIL, Cobit)
• Audit Management (pre-audit preparations, audit escort and hosting, post-audit remedation, vendor audits)
• Comply with current regulations:
• 21 CFR Part 11 compliance (Open link to FDA announcement here)
• EudraLex (EU) Volume 4 - GMP - Annex 11: Computerised Systems (revision January 2011) 

We invite you to explore our website and learn more about our capabilities, spectrum of services, contact information, and much more.

comes compliance intelligence means lean, smart and unique quality and validation management provided by topnotch experts. For further information, download our company brochure: Company Brochure (PDF - 0,5 MB)

What to do next?

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