Regulatory consulting case studies

A top 20 pharma subsidiary scaling plasma-derived therapies asked ICON to review their processes and plan for growth. With plasma reliant on donations, new centers were opening to meet demand and ensure patient access to life-saving treatments.

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.

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.

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.

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.

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.

Following a corporate acquisition, the ICON Regulatory Technology & Information Management (RTIM) team was engaged by a mid-sized life sciences company to re-design, configure, and deploy the existing EDMS to a new business unit.

The European Medicines Agency (EMA) is in the process of implementing IDMP standards that specify standardized definitions to identify and describe medicinal products for human use only.