GxP Compliance Services

Patient safety is paramount when performing clinical studies or using pharmaceutical products or medical devices. By applying Good Practices (GxP), quality guidelines and regulations, companies within the healthcare and life sciences industries can ensure their products are safe for use.

Whether you are a start-up company in need of professional expertise to set up and implement a business model for Quality, Validation, and Compliance, or a global life sciences company in need of resources to execute and manage validation and compliance projects, CTG’s Regulatory Compliance (RC) practice is fully equipped to get the job done and satisfy your expectations. Our services are based on lean, scalable, risk-based, and agile concepts, and were designed using industry best practices.

Services

Compliance Assessment and Remediation: Provides a comprehensive picture of all compliance gaps and weaknesses, resulting in a remediation roadmap.
Vendor Audits: Delivers a comprehensive report of your business partner(s), including risks that could impact your business.
Application Management Agile Computer System Validation: Ensures the validated state of your enterprise-wide system landscape or specific systems. Our System Validation offerings include:
  • Enterprise-wide Systems Validation
  • ERP/SAP Validation
  • Outsourced Spreadsheet Validation
IT Infrastructure: Helps ensure that your IT Infrastructure has been installed in a controlled and documented manner and remains under control.
Equipment Qualification: Enables qualification of a wide range of laboratory and manufacturing equipment according to the latest ISPE and applicable standards (e.g., Pharmacopeia).
Agile Software Development: Supports software development through CTG’s agile development (e.g., Scrum) team members, who are fully trained in the Compliance and Validation requirements and understand the unique requirements of highly regulated environments.
Training: As part of CTG Academy, offers courses that allow your organization and staff to navigate compliance topics.
Coaching: Provides the training necessary to coordinate, manage, and control validation and quality projects.
 

VALIDATION CONSULTANTS

Our Validation Consultants play a pivotal role in assessing, implementing, remediating, and maintaining GxP Compliance in your organization. We invest heavily in the rigorous training, skill, and competence development of every consultant, which results in expertise across many different business domains, including:

  • Proficient in the fields of science, combined with deep information technology, information security, and validation expertise
  • Achievement of critical certifications, such as Project Management, CISM, ISO 27001 Lead Implementer, ISO 22301 Lead Implementer, and more