ICON leads portfolio transition of growth & non-growth products

A sponsor hired ICON to perform global regulatory affairs services (e.g., regional leads, CMC, labelling, publishing, and submission management) for a recently acquired portfolio of registered products. For this purpose, ICON needed to utilise staff with portfolio-specific product knowledge and experience.

Processes and systems for managing the new portfolio were not yet harmonised and differed from the Marketing Authorisation Holder’s (MAH’s) processes and systems. Many products had ongoing key business deliverables and goals attached, including expansion and maintenance into major international markets.

The team identified the key activity milestones and timelines required to transition the portfolio. In parallel, ICON identified and provided product training and system access to the team, strengthening team compliance and allowing for the continued delivery of regulatory activities for the transitioned products.

ICON leveraged team members that had transitioned from the sponsor, given their systems expertise and process knowledge for the acquired products. Product handover meetings were held between ICON and the client’s transitioning staff, in conjunction with the implementation of a handover document that maximised knowledge transfer.

A series of focused submission working groups for key submissions were established to closely monitor deliverables and guarantee tight timelines were met.

ICON successfully delivered the key global expansion regulatory submissions on time and achieved the client’s goals. The transition strategy allowed our team to quickly get up to speed, resulting in faster project delivery for the sponsor. We accomplished these successes despite managing the COVID-19-related challenges our industry faced.

ICON’s strategic and operational regulatory expertise, internal processes, and product knowledge gained from the acquired company personnel enabled ICON to manage the transition thoughtfully while ensuring compliance and increasing the client’s reputation in the industry. Our team continues to manage this portfolio, driving the delivery and execution of global regulatory strategies and submissions.