We are now in a period of significant regulatory developments. Even as many of the leading pharmaceutical and biotechnology companies have received significant warning letters and consent decrees, leading regulatory agencies such as the U.S. Food and Drug Administration (FDA) are making significant changes in the way the development and manufacturing of medicine is regulated. Light Pharma has many years of experience with regulatory issues. Light Pharma routinely tracks these regulatory developments and puts them into context.

• Regulatory Policy: What are the recent regulatory developments with policy implications? What are the major trends? What implications are they likely to have?
• Warning Letters and FDA 483 Observations: What are the recent trends? What are the implications?