Regulatory Intelligence
Our Regulatory intelligence services are specialized offerings that provide comprehensive, up-to-date information and analysis on regulatory requirements, guidelines, policies, and trends affecting drug development, approval, and marketing.
Key aspects and benefits of
Regulatory Intelligence Services in Pharma
Monitor and track regulatory changes at local, national, and international levels. This includes updates from regulatory agencies such as the FDA (Food and Drug Administration) in the United States, EMA (European Medicines Agency) in Europe, PMDA (Pharmaceuticals and Medical Devices Agency) in Japan, and other regulatory authorities.
Interpret and Analyze regulatory developments to provide insights into their potential impact on drug development, registration, and commercialization strategies.
Providing early warnings about upcoming regulatory changes or trends enables pharmaceutical companies to proactively adjust their strategies and operations to remain compliant and competitive.
Regulatory intelligence services also offer insights into the regulatory strategies of competitors, including their product development pipelines, regulatory submissions, approvals, and compliance issues. This helps companies benchmark their own performance and identify opportunities or risks.
Identifying potential compliance gaps, addressing regulatory hurdles, and developing risk mitigation strategies for the products.
Provide guidance and support for preparing regulatory submissions, including marketing authorization applications, Investigational New Drug (IND) applications, New Drug Applications (NDAs), and other regulatory filings.
Regulatory intelligence services also offer training programs, workshops, webinars, and educational resources to help pharmaceutical professionals stay informed about regulatory requirements and compliance standards.