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.
Regulatory Compliance Associates (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, Regulatory Compliance Associates® offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.
Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance Associates team knows the unique inner workings of the regulatory process.
Client Solutions
Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, Regulatory Compliance Associates will guide you through every pharmaceutical consulting step of the regulatory process and create a customized approach depending on your product and your pharma company’s individual needs. Our regulatory compliance clients include:
- Companies new to FDA, Health Canada or EU regulations and regulatory compliance
- Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
- Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
- Law firms seeking pharmaceutical consulting firm expertise in the remediation of warning letters, consent decrees, 483’s or import bans
Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting companies with industry experts experienced in complexities of the pharmaceutical and biopharmaceutical industries. Our pharma consulting expertise spans all facets and levels of Regulatory Affairs, from Regulatory Support for New Products to Life Cycle Management, to other services like Outsourced Regulatory Affairs, Submissions, Training, and more.
As your partner, we can negotiate the potential assessment minefield of regulatory compliance services with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.
- New Product Support
- Product Lifecycle
- Other Regulatory Services
- Combination Products
The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance Associates, we offer the pharma consulting experience and pharma consultants necessary to guide you through the quality compliance process.
- Assessments
- Audits
- Regulatory Agency Response
- Preparation and Training
- Inspection Readiness
- Data Integrity
Regulatory Compliance Associates Quality consulting includes assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. Our pharma consultants understand the strategic thinking needed to align your business needs and goals. Regulatory Compliance Associates quality assurance services include quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality, and we excel in transferring pharma consulting knowledge to your organization.
- 21 CFR Part 11
- Data Integrity
- Manufacturing Support
- Facility Support
- Quality Metrics
Regulatory Compliance Associates has a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. Our pharma consultants know how to partner with executive, legal, and communication teams. Each RCA pharma consulting Expert will develop a response that will be accepted by the regulatory agency and be realistic to execute.
Regulatory Compliance Associates pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues. In addition, each Regulatory Compliance Associates pharma consulting Expert understands compliance enforcement. We’ll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations.
- Regulatory Action
- Regulatory Compliance
- Regulatory Enforcement
- Warning Letter
- 483 Observation
- Oversight Services
- Risk Management Plan
About Regulatory Compliance Associates
Regulatory Compliance Associates® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science challenges:
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 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.
Commitment to Quality
Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.
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