We are now in a period of significant regulatory change. Even as many of the leading life sciences companies are in the midst 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?