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.
Mar 02, 2013

In today's competitive business environment, life-science companies run lean, particularly in terms of personnel. The regulatory affairs (RA) and quality assurance (QA) functions create extra complexity for pharmaceutical companies because needs vary greatly depending on the life cycle of the organization. An early-stage pharmaceutical manufacturer needs strategic RA leadership as the new drug is registered and filed with regulatory agencies. Once the RA strategy and filings are in place, the company's regulatory needs often transition to ascertain that the drug or product is kept up-to-date with the regulatory expectations, new requirements, and changes in the manufacturing process. The quality function typically sees a similar pattern of heavy strategic need followed by a maintenance need.

For a small- or mid-market company, this shift can create challenges for appropriate in-house staffing, particularly if the company has one or a limited number of products. It can mean an expensive hire early in the company's life cycle, followed by a period when the executive is too much horsepower for the maintenance needs of the company.

Table I: Outsourcing options.
Outsourcing can provide a better match to changing RA/QA strategic needs through the company lifecycle. There are three major options commonly used: Sole RA/QA practitioner, enterprise consulting firm, or dedicated RA/QA consulting firm (see Table I).


With corporate downsizing, many executives with quality and regulatory expertise are establishing small consulting practices. With their long and accomplished resumes, they easily attract pharmaceutical clients. Sometimes, the clients are former employers and colleagues, who trust and value their expertise, but can't afford to have these sole practitioners on the full-time payroll. This arrangement enables the pharmaceutical company to hire RA/QA staffers as needed, while using the outsourced QA/RA executive on an as-needed basis for strategy and major projects.

Problems can arise with this model when the pharmaceutical company changes scope or scale beyond the consultant's capabilities, or when the sole practitioner finds a full-time job and decides a steady paycheck with benefits is better than consulting. So, while using the sole-practitioner model, the pharmaceutical company may be best served by maintaining a rolodex of multiple subject-matter experts in case backfilling is needed.


Enterprise consulting firms offer services in more than one functional area, typically operations and financial areas. These firms can be ideal for early- and mid-market pharmaceutical companies because they represent one-stop shopping for executive leadership in multiple areas. Often these firms are large and can attract the best talent, which the pharmaceutical company can access as needed.

Problems can arise with this model when the consulting firm lacks a deep stable of RA and QA talent, but rather brings in executives as needed. This arrangement can mean delays in getting help and also can mean a higher price tag when the firm outsources QA/RA talent and adds a markup. So the pharmaceutical company may be best served by validating the talent they receive, and by communicating their QA/RA needs well in advance to their enterprise consultants.

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