Quality and Regulatory Leadership: Right-Sizing Need and Cost - This article examines the options to best match needs and spending for quality and regulatory leadership. - BioPharm International


Quality and Regulatory Leadership: Right-Sizing Need and Cost
This article examines the options to best match needs and spending for quality and regulatory leadership.

BioPharm International Supplements
Volume 26, Issue 3, pp. s14-s16


The focused QA/RA consulting firm is a blended solution. Because quality and regulatory is their only business, these firms generally provide good talent at a fair price. Because they have multiple consultants, they should be able to scale or change direction, unlike sole practitioners.

Problems can arise in identifying and vetting the QA/RA firm because there are few large players with national reputations. The pharmaceutical company may be best served by establishing a due diligence process that matches their needs to the consulting firm's strengths.

The following cases illustrate several approaches that provide QA/RA expertise while saving money.


One established pharmaceutical company evaluated its product lifecycle and decided to implement a series of changes surrounding the API. Retiring the old API, transitioning to the new API, and the related activities were simply beyond the bandwidth of the quality and regulatory team in place. It's not uncommon for consultants to be called upon for projects like this, but the pharmaceutical company recognized there would be economies of scale by using the same team of outside experts over the course of multiple projects, avoiding the ramp-up time and discovery fees that would be associated with multiple consulting engagements. Additionally, the pharmaceutical company found that having local experts not only saved on travel costs, but also allowed the consulting firm to become part of the team, adding value to ad hoc meetings, and integrating into their quality and regulatory functions without being on the payroll.


A Fortune-500 company was planning a new drug/device product development using a disruptive technology. Recognizing that risk insulation and speed-to-market would be crucial for early adoption and success, the company decided to create a new subsidiary to develop and launch the product.

The seasoned QA and RA management decided to stay with the Fortune 500 enterprise instead of joining the subsidiary, whereas some of the early- and mid-careerists were attracted to the startup venture. The subsidiary realized they had staff to implement but lacked QA/RA leadership and deep expertise.

The RA/QA consulting firm was brought in to complete product development, direct regulatory filings and compliance activities, and to set up a quality-management system (QMS). The subsidiary had originally planned to adopt the QMS of the parent company but the consulting firm pointed out the need to right-size the legacy QMS for the new start-up subsidiary. With ongoing outsourced QA/RA expertise and their implementation staff, the subsidiary was able to launch the product, comply with all regulations, and implement their QMS systems without hiring expensive executives. Additionally, some of their staff used the consulting firm as their mentors and used this opportunity to step up. Over time, there were some internal promotions within the QA/RA team because the subsidiary had created a culture of grooming and promoting from within.

blog comments powered by Disqus



Bristol-Myers Squibb and Five Prime Therapeutics Collaborate on Development of Immunomodulator
November 26, 2014
Merck Enters into Licensing Agreement with NewLink for Investigational Ebola Vaccine
November 25, 2014
FDA Extends Review of Novartis' Investigational Compound for Multiple Myeloma
November 25, 2014
AstraZeneca Expands Biologics Manufacturing in Maryland
November 25, 2014
GSK Leads Big Pharma in Making Its Medicines Accessible
November 24, 2014
Author Guidelines
Source: BioPharm International Supplements,
Click here