The journey of developing and commercializing combination drug/device products is filled with challenges, primarily due to the non-harmonized global regulatory frameworks. As discussed at the recent 2023 Combination Products Summit, manufacturers face significant hurdles because [...]

Business continuity planning (BCP) is essential for the success of any enterprise, but it’s particularly crucial for companies in the life sciences industries, where criticality and compliance with FDA regulations may be impacted by a [...]

For companies in the Life Sciences industry, today’s climate—a mixture of competition, regulation, increasing consumer awareness, and continually evolving knowledge and capabilities—presents manufacturers of pharmaceuticals, medical devices, biologics, and combination products with a choice: maintain [...]