Regulatory Consulting Case Studies

Encompassing over 1,000 experts across more than 100 countries we deliver customised, end-to-end regulatory solutions tailored to your needs.

RIM Data and System Assessment to ensure IDMP compliance

RIM System Configuration and Data Assessment is pivotal in regulatory business planning. It also helps in organising product registration process to track and manage all regulatory activities.

Regulatory Technology Services

Software companies are incentivised to implement their solutions as quickly as possible, often leaving clients in a situation where the regulatory technology does not support the business process.

Regulatory technology services

Software companies are incentivised to implement their solutions as quickly as possible, often leaving their clients in a situation where the technology doesn’t support the business process, users are frustrated, and return on investment is questionable.

Full manual creation in target source

The client received an audit finding relating to the insufficient tracking of investigational and post-approval commitments. Although investigational and post-approval commitments were previously out of scope for the RIM system dataset, ICON determined to increase the dataset scope within the RIM system to track commitments.

Easing the regulatory burden

Various regulatory agencies, such as the European Commission, the EMA and national Head of Medicines
Agencies (HMA) have all published new recommendations on how to manage clinical trials in the wake of the coronavirus disease (COVID-19) pandemic.

Team delivered an initial US BLA and EU MAA Major Amendment (Gastroenterology)

ICON’s Regulatory Project Managers (RPMs) were approached by a client to deliver, in parallel, an initial US Biologics License Application (BLA) and an EU Marketing Authorisation Application (MAA) Major Amendment for a new formulation within an existing program.

Global expansion and a reduction in approval timelines

ICON’s Regulatory Project Management (RPM) team was approached by a client to help establish a global footprint and reduce the approval timelines for the first wave of targeted countries located in the US, Europe, and Asia Pacific.

Automated conversion and load, including manual enrichment

ICON was asked to support a client with migrating data from an existing Regulatory Information Management (RIM) system into a new system. During migration, the ICON team needed to ensure the safety reporting requirements were correctly described in the new system as current data were incorrect and/or incomplete.