regulatory affairs

Do EMA and FDA review outcomes for new active substances (NASs) align?

In order to better assure the safety and efficacy of pharmaceutical products, the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have taken steps to align their activities and goals. The Centre for Innovation in Regulatory Science (CIRS) and Sanofi partner on a study to evaluate their progress to date.   The common […]

Q&A: Five simple strategies to ensure regulatory compliance when globalizing your development program

Industry expert Lawrence Liberti shares his tips for tackling the complexity and diversity of regulatory requirements in divergent markets While expansion into new markets potentially introduces tremendous opportunities to scale your business, globalizing your development program doesn’t come without risks. Whether you’re a pharma or biotech from an established region looking to expand into an […]