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

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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

EXAMPLES OF BENEFITS FOR EARLY-STAGE COMPANIES

Example one

A biotech startup was in a Phase II clinical trial and struggling with its cash-burn rate. They had a four-person quality team in place in anticipation of future needs. Their QA/RA consulting firm recommended managing work more efficiently, scaling back to two analyst-level personnel and augmenting with occasional consultation by outsourced quality experts. This model was possible, because the quality systems were already in place but didn't need such heavy staffing. By transferring expense away from the quality function, they were able to deploy additional resources to the scientific and product development area, their greatest need.

Example two

Another early-stage company engaged a consulting firm because the owners were not familiar with the regulations surrounding their medical device. The team had a business plan in place, a solid IP platform, and a distribution plan, but the company lacked a regulatory and quality pathway.

A consulting firm provided the company with an overview of the RA and QA requirements. Because the leadership team was bootstrapping the company, they decided to purchase off-the-shelf quality documents, and asked the consultants to fill the gaps. The consulting firm began a steady process of backfilling where the firm needed help, such as matching the purchased standard operating procedures with the business needs and remediating the product development in accordance with the developing QMS. As the launch date for the new product approached, the consulting firm helped the company implement corective and preventive actions and a complaint system, along with an internal audit plan.

The consulting firm performed all this QA/RA oversight and backfilled the firm's gaps while working within a fixed monthly fee, helping the firm's cash flow requirements.

The product has since launched and is a commercial success. As the company continues to grow and scale, the consulting firm continues to provide ongoing support as the outsourced QA/RA manager, working hand-in-hand to augment the firm's capabilities, while keeping their expenses to a manageable level.

CONCLUSION

Outsourcing quality and regulatory expertise can bring needed experience while saving costs. As companies grow and scale, they need flexible models for meeting their evolving compliance needs, and outsourcing can provide value.

Brian Matye is the general manager for the Southeast division,
Rick Davis is the director, ASQ CQA,
; and Dr. Frans Dubois is a management consultant for biotech companies,
; all at Regulatory Compliance Associates, Kenosha, WI.


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