EXAMPLES OF BENEFITS FOR EARLY-STAGE COMPANIES
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.
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.
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, b.matye@ rcainc.com
Rick Davis is the director, ASQ CQA, firstname.lastname@example.org
; and Dr. Frans Dubois is a management consultant for biotech companies, email@example.com
; all at Regulatory Compliance Associates, Kenosha, WI.