Even after a drug earns regulatory approval, the compliance journey continues. Particularly for manufacturers that have multiple products on the market, it can be costly and inefficient to hire full-time staff to manage regulatory filings and unforeseen challenges throughout the product lifecycle.
Dedicated, full time equivalent (FTE) models can provide a more cost-effective, scalable and flexible solution for manufacturers who want to avoid the inefficiencies and overhead costs of hiring full-time staff to manage the regulatory aspects of their post-approval journey.
Through our FTE model, Cardinal Health Regulatory Sciences brings a team of regulatory consulting and medical writing experts together who work as an extension of the pharmaceutical manufacturer’s team, helping to establish regulatory strategy, developing consistent, submission-ready documents and quickly managing unforeseen regulatory challenges.
We’ve leveraged our FTE models to support the post-approval journey for pharmaceutical companies. Here are three real-life examples of why FTE models make good business sense: