Regulatory Intelligence

The life sciences industry is going through a period of significant regulatory change. 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, field alerts, observations, warning letters and consent decrees have provided a high degree of visibility to issues of regulatory compliance and quality. Light Pharma help organizations track these regulatory developments and puts them into context.

• What are the recent regulatory developments with policy implications (e.g., ICH Q8, Q9, Q10, Q11, Q12, Q13, Q14, EU GMP Annex 1)? What are the major trends and initiatives (Quality Metrics, Quality Management Maturity, Quality Culture)? What implications are they likely to have?
• What are the recent trends in recalls, observations, compliance status, regulatory action including warning letters and import alerts? What are the implications?

We have developed a large database of the underlying characteristics of the warning letters and site inspection observations. We have built this into a Quality Intelligence™ tool which can provide you with invaluable help to quickly understand:

•  How your recalls, letter or observations compare with others
• Potential underlying causes of site inspection observations
• Common aspects of recent site inspection observations
• Severity of a particular letter or site inspection observation compared to others in the past
• Categorization of site inspection observations by system and subsystem