FTE models make good business sense: Three real-life examples
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.
A dedicated team of regulatory consulting and medical writing experts who work as an extension of a pharmaceutical manufacturer’s team, can help establish regulatory strategy, developing consistent, submission-ready documents and quickly manage unforeseen regulatory challenges.
FTE models can be used to support the post-approval journey for pharmaceutical manufacturers. Three real-life examples where FTE models make good business sense include:
- Averting drug shortages despite natural disaster
- Maintaining compliance during M&A activity
- Effectively managing compliance during manufacturing site shutdowns – even when full-time staff is not available
Read more about these examples and learn how FTE models can help manufacturers maintain compliance and make strategic use of time and expertise, while reducing costs.
Ben Porter is Director, Chemistry, Manufacturing and Controls for Cardinal Health Regulatory Sciences