Small or emerging life science organizations often put off outsourcing Quality and Regulatory executives, exposing the company to risk or worse. Other organizations add full time leaders before they have full time needs, resulting in over-spending. This article suggests another model: leveraging Quality and Regulatory agencies to best match needs and variable spending.

In today’s competitive business environment, life science companies run lean, particularly in terms of regulatory data personnel. However, the complexities of the regulatory (RA) and quality (QA) functions in pharmaceuticals, biotech, and medical devices require levels of expertise and leadership.

In our compliance consulting practice, it’s not uncommon for life science companies to engage our services for special projects. However, we’re increasingly seeing regulated business clients seek on-going compliance counsel from us after the special project is completed. This enables them to maintain a baseline level of QA / RA expertise without the hefty price tag of a full time equivalent. The following four cases illustrate various approaches that provide QA / RA expertise while saving money.

 

Regulatory Agency Insights

One established pharmaceutical company evaluated its product life cycle and decided to implement a series of changes surrounding the Active Pharmaceutical Ingredient (API). Retiring the old API, and transitioning to the new API were beyond the bandwidth of the team in place. It’s not uncommon for consultants to be called upon for expertise in regulation examples like this.

Likewise, the pharma company recognized economies of scale with regulatory costs by using the same team of experts over the course of multiple projects. The pharmaceutical consulting firm would have less ramp-up time and discovery fees with multiple engagements. Additionally, the pharma company found that having local experts saved on travel costs but could also work on site. This added value to adhoc meetings to integrate into their quality and regulatory functions.

 

Regulatory Agencies Examples

Our regulatory agencies examples start with a fortune 500 company planning for a new product development using a disruptive technology. Recognizing that risk insulation and speed to market would be critical for early adoption and success, they decided to create a new subsidiary to develop and launch the product.

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

 

Compliance Assurance

Regulatory Compliance Associates® Inc. 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. However, our technical experts added strategic value by right-sizing the legacy QMS as it was transitioned out.

With our 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, their staff saw one of the pharmaceutical consulting firms they worked with as mentors. Leadership employees also used this opportunity to step up their contributions. Over time, there were promotions within the QA / RA team as a culture of grooming employees from within developed.

 

Early Stage Regulatory

A biotech start-up was in stage II clinical trial and struggling with its cash burn rate. They had a four person quality team in place in anticipation of future needs. We recommended that they manage work more efficiently, scaling back to two analyst level personnel and augmenting with occasional consultation by outsourced quality experts.

This Regulatory leadership model was possible because the QMS was already in place but didn’t need heavy staffing. By minimizing expenses inside the function through outsourcing quality, the client’s resources were redeployed to the scientific and product development.

Another early stage company approached our firm because the owners were not familiar with the regulations surrounding their medical device. The client had a business plan, solid IP platform and a distribution plan, but they lacked a regulatory pathway. This is where the top pharmaceutical consulting firms can provide regulatory support. 

Our firm provided the client with an overview of Regulatory Affairs and Quality Assurance strategy. Since they were bootstrapping the company, they asked us to fill the skill gaps through outsourcing quality experts across the functions. We began a steady process of backfilling where they needed new product support.

As a result, standard operating procedures were implemented into the business unit needs. A risk assessment strategy was developed for remediating their product development in accordance with the developing QMS.

 

Corrective and Preventative Actions 

As the launch date approached, we finalized the CAPA and complaint system installation. A refined internal audit plan included virtual options for connecting with facilities around the world. RCA performed all this QA / RA regulated products oversight and backfilled their gaps while working within a fixed monthly fee.

The product has since launched and is a commercial success. As the company continues to scale, we continue working to augment their capabilities. The true benefit of this regulatory compliance project was on-demand expertise while keeping the client’s technical regulation expenses manageable.

 

About RCA

Regulatory Compliance Associates^® (RCA) provides FDA inspection consulting services to the following industries for resolution of compliance and regulatory challenges:

• Pharmaceutical
• Biologic & Biotechnology
• Sterile compounding
• Medical device
• Lab Testing

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

• Founded in 2000
• Headquartered in Wisconsin (USA)
• Expertise backed by over 500 industry subject matter experts
• Acquired by Sotera Health in 2021

 

About Sotera Health

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health^®.

Sotera Health Company, along with its three best-in-class businesses – Sterigenics^®, Nordion^® and Nelson Labs^®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.

 

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