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 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
guidance 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
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 Global Validation Service Profile |
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Copyright CTG, 2008. All rights reserved
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