RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

Regulatory Focus™ > News Articles > 2020 > 5 > FTE models make good business sense: Three real-life examples

FTE models make good business sense: Three real-life examples

Posted 13 May 2020 | By Ben Porter 

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
In each of these examples, pharmaceutical manufacturers do not have to lose valuable time navigating the often-complex and costly process of hiring additional resources to respond to emergent needs; nor do they need to waste time renegotiating unit-based contracts. They can turn to their FTE team, which works as a true extension of theirs, to ensure each of these challenges are handled correctly the first time by experienced regulatory experts who can successfully manage regulatory challenges.

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

This article is sponsored and does not reflect the views or opinions of RAPS. The sponsor is solely responsible for the content presented.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.