Responding to New Regulatory Requirements in In-Vitro Diagnostics

The chief of staff for the quality organization of an F200 life science company needed to establish and implement a compliant workstream related to the specific requirements of current in-vitro diagnostics regulations (IVDR) and the development of IVDR capabilities. Given the recent changes to the regulations, the organization lacked the necessary internal expertise on the matter. Given the complexity and importance of the project, they felt execution-oriented consultant support was needed.

Business Talent Group (BTG) presented and deployed an IVDR expert paired with a former Bain consultant project manager, both with extensive pharma experience. The consultants developed key operational processes and implemented standardized workflows based on industry best practices and applicability to specific business requirements for business continuity. Project deliverables included a current gap assessment, a comprehensive quality plan, training, coaching, and mentoring to the organization on IVDR language, and a communication strategy to deliver throughout the organization on changes and impacted functional areas.

About the Author

Emily Best

Emily is a digital marketing strategist with over a decade of experience in developing programs to support revenue growth and create memorable customer experiences. She enjoys gardening, traveling, and exploring new culinary delights.

More Content by Emily Best
Previous Article
Developing Foundational Frameworks for Regulatory Affairs
Developing Foundational Frameworks for Regulatory Affairs

The Head of Regulatory Affairs at a F500 biotech was looking to mature the regulatory affairs function and ...

Next Article
Pharmacovigilance PMO to Strengthen PV Organization
Pharmacovigilance PMO to Strengthen PV Organization

A Fortune 500 pharmaceutical company was looking to build a pharmacovigilance organization that was flexibl...


Talk with BTG to learn more about our on-demand talent.

First Name
Last Name
I would like to receive the latest expert insights and news from Business Talent Group.
By registering, you agree to the processing of your personal data by Business Talent Group as described in the Privacy Statement.
View our Privacy Policy and Cookie Policy
Thank you! We will be in touch shortly.
Error - something went wrong!