Regulatory Compliance

Overview

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The life sciences industry is going through a period of significant regulatory developments. A number of initiatives have 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?

Regulatory Developments

 
We are now in a period of significant regulatory change. Even as many of the leading life sciences companies are in the midst of significant recalls, warning letters and consent decrees, leading regulatory agencies such as the U.S. Food and Drug Administration (FDA) are making changes in the way the life sciences and health care R&D, and operations are regulated. Light Pharma has many years of experience with regulatory issues. Light Pharma tracks these regulatory developments and puts them into context.

  • Regulatory Policy: What are the recent regulatory developments with policy implications(e.g., ICH Q8, Q9, Q10)? What are the major trends? What implications are they likely to have?
  • Recalls, Warning Letters, and Regulatory Observations: What are the recent trends? What are the implications?

Compliance Assessment

  • Have you recently recalled a product or received a warning letter from a regulatory agency?
  • Have you recently received an FDA 483 list of observations?
  • Are you concerned about this happening in the near future?


 
In the recent regulatory environment, a large number of life sciences companies have been recipients of one or more FDA 483 observations and Warning Letters. We have developed a large database of the underlying characteristics of the letters and observations. Using our PI™ framework and our vast experience in the details of life sciences operations, batch record analysis and investigations we can provide you invaluable help to quickly understand:

  • How your recalls, letter or observations compare with others
  • Potential Underlying Causes of Such Observations
  • Common Aspects of Many of the Recent Regulatory Observations
  • Severity of a Particular Letter or Observation Compared to Others in the Past
  • Categorization of Regulatory Observations into Their Components
     

Become a Client

Light Pharma's Services leverage years of experience, focus and insight.


If you are interested in utilizing Light Pharma's Regulatory Compliance services, click here.

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