About Us
     Investors
     Partners
     Press
     Careers
     
     Markets
     Services
A life sciences company must invest millions of dollars in achieving regulatory compliance while simultaneously continuing to develop new products and maintain profitability. At the same time, regulatory requirements have introduced complex technologies and procedures into every facet of the business. CTG LSS practitioners and business consultants experienced in FDA, EU, OECD, and ICH regulations and guidances deliver a full range of services that include:
  • Assess systems for GxP and Prescription Drug Marketing Act (PDMA) applicability
  • Conduct risk assessments to determine compliance and validation objectives across all GxP disciplines
  • Assess the client's current Part 11 risk position and develop corrective actions plans as indicated
  • Provide consulting services in support of electronic submissions for new drug applications
  • Deliver regulatory compliance awareness training to in-house staff, tailored to corporate polices
  Global Validation Service Profile   
  Overview
  IT and Validation
  Strategy
  Regulatory Compliance
  Software and System
  Development
  Adverse Events
  Reporting and CAPA
  Audit Services
  Good Manufacturing
  Practices
  Contact Us
  Success Stories
Copyright CTG, 2008. All rights reserved