Small Organizations, Big Regulatory Strategy
By Angela Johnson, MSE, PMP, RAC -
Published 30 January 2017
This article discusses how small and young organizations, including start-ups, build powerful regulatory strategy programs that complement their research and business development efforts. Established businesses also can learn from their innovative approaches. These include navigating incentives, understanding and utilizing technology tools for regulatory intelligence like social media and crowdsourcing, and embracing a team mentality to build agile and efficient regulatory programs with a strong underlying alignment with business development.
Categories: Features, Asia, Europe, US, EMA, FDA, Biologics and biotechnology, Drugs, Regulatory strategy, Submission and registration
Tags: Regulatory Strategy, SMEs
EMA Boasts Success of Tools for Small- and Medium-Sized Companies
By Michael Mezher -
Published 04 February 2015
The European Medicines Agency (EMA) says that its tools designed to aid micro-, small- and medium-sized enterprises (SMEs) have increased those companies’ success in obtaining authorization for their products. The agency released a report this week highlighting the growth and success of the program.
Categories: Biologics and biotechnology, Clinical, Drugs, Quality, Regulatory strategy, Research and development, Submission and registration
Tags: SMEs, Small and Medium Sized Enterprises, Scientific Advice