Celegence published a thought leadership blog exploring when an NBOp is required under Article 117, what Notified Bodies assess, key documentation and GSPR considerations, and planning for NBOp timelines and lifecycle changes.

Celegence provides services and solutions to support the Life Sciences industry with regulatory affairs operations and strategy. We aim to help Life Sciences companies navigate complex global regulatory requirements by providing depth of experience and an extensive delivery capability. As regulatory specialists, we work across all phases of the product lifecycle from regulatory strategy, authoring, and all aspects of established product maintenance, including submission management, publishing and health authority interaction. We leverage a global team of consultants to provide local regulatory insight, strategy and intelligence. Our mission is to collaborate with our customers to deliver Regulatory Affairs efficiency that allows them to focus on what matters most: providing exceptional patient value. We support companies in ensuring regulatory compliance across the globe by providing fully trained resources who understand the regulations and can leverage this knowledge to assist our clients in their day-to-day operations. Celegence is a privately owned business headquartered in Chicago, IL with offices in the U.K., Europe, and Bangalore(India).

Founded 2017