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How to successfully integrate external expertise to minimize your exposure to regulatory risk

4 min read


(Photo: Norman Baylor, President and CEO, Biologics Consulting)

This post is sponsored by Biologics Consulting

Norman Baylor is the president and CEO of Biologics Consulting. He joined Biologics Consulting after 20 years with the FDA, where he most recently served as director of the Office of Vaccination Research and Review. In his previous position at the FDA’s Center for Biologics Evaluation and Research, he was responsible for planning, developing and administering CBER’s national and international programs and operational activities involving vaccines and related products. In this interview, he discusses how consulting firms work with innovators and manufacturers throughout the product development and regulatory process.

Question: What are some of the challenges companies face in navigating the regulatory approval process?

Norman Baylor: Pharmaceutical and biotechnology companies are presented with a myriad of challenges due to the highly regulated environment within which they must operate.  Over the past few years, the industry has seen a proliferation of regulatory changes they must observe to ensure ongoing compliance. Once product development enters the regulated environment, there are challenges that must be overcome. Companies must adhere to specific regulatory compliance obligations, such as Good Laboratory Practices (GLP) for preclinical studies. Clinical studies must be done under Good Clinical Practices (GCP), and chemistry, manufacturing and control procedures must be done under current Good Manufacturing Practices (cGMP) throughout the life cycle of their products.

Looking to the future, the regulatory landscape is expected to be increasingly challenging and uncertain. Regulatory authorities continue to increase their compliance oversight and enforcement activities for existing laws, while at the same time, new regulations and guidance are being introduced by regulators, and these will directly impact how pharmaceutical and biotechnology companies conduct business.

Q: How do you work with companies through each stage of the product life cycle to determine the best strategies to deploy?

NB: Our experts at Biologics Consulting partner with clients to assess their product development plan, identify the appropriate pathway for approval, define all applicable scientific and regulatory requirements and craft a customized product development strategy that minimizes cost and time to clinical trials, regulatory approval and commercialization. Our consultants leverage their unique “insider” perspective to interpret agency requests and communications, as well as provide guidance on the latest Agency thinking, positioning companies’ new products for a successful outcome.

Q: What types of expertise should companies look for when hiring a consultant?

NB: Companies should exercise diligence in selecting a consulting firm that can provide subject matter experts who have extensive knowledge and experience in developing regulatory strategies, target product profiles, clinical trial design and quality systems. Biologics Consulting has successfully assisted clients globally to address nonclinical, clinical, product development and regulatory compliance challenges. The cornerstone of this success is found in our team of consultants and professional services staff, comprising subject-matter experts with decades of industry and/or FDA experience.

Q: What are the advantages of working with a partner through the process?

NB: Tapping into outside expertise can uniquely position companies to have a competitive advantage to guide products to approval and meet post-approval requirements.  Furthermore, partnering can save valuable time and allows internal teams to focus on other pipeline projects. When considering an outsourcing partner, companies need to make sure the partner they choose is a good fit for their business needs.

At Biologics Consulting, we work to build a relationship where we can communicate and execute as partners to the client’s success in a candid and respectful way, allowing us to surface issues and opportunities more readily and achieve solutions our clients have come to expect. With Biologics Consulting, we operate as a true extension of the client’s team and integrate ourselves seamlessly into their existing product development processes and team dynamics. To learn more about how we assist companies through the product development and regulatory approval process, please visit our website.