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Regulatory Compliance

*Strategic Consulting

*Six Sigma

*Regulatory Compliance

*Regulatory Developments
*Compliance Assessment

*Process Management

*Technology Assessment


We all know how Adam said to Eve: 'My dear, we live in a period of transition.' -- Vida D. Scudder, The Privilege of Age.

The life sciences industry is going through a period of significant regulatory developments. A number of initiatives have been recently been launched by regulatory bodies throughout the world including the United States Food and Drug Administration (FDA). The recent spree of Recalls, Warning Letters and Consent Decrees have provided a high degree of visibility to issues of regulatory compliance and quality. Our Regulatory Compliance services can help you keep abreast of these developments and assess your state of compliance.

  • Regulatory Developments: What are the important recent regulatory developments(e.g. ICH Q8, Q9, Q10)? What is their potential impact on the high technology, life sciences and health care industry?
  • Compliance Assessment: Where does your company stand in terms of compliance? How does this compare with other companies?
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