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Regulus CMC (“Regulus”) is a provider of Regulatory, Quality, and Technical services for the biotechnology, pharmaceutical, and medical device industries. While the company’s name showcases Chemistry, Manufacturing, and Controls (CMC), this is only one of its core capabilities. At Regulus we embrace an *Alliance Parter* business model, which was born out of years of rich collaboration and is consistently reaffirmed with every successful project and new client achievement. “Regulus” in our company name embodies our strongly-held belief that we all shine brightest when we’re working together toward a common goal — just as the Regulus star cluster in the constellation Leo ( also known as ‘The Heart of the Lion’ ) owes its brilliance to the combined light of the stars comprising it.
The special ingredient that makes a Regulus team a far better choice for your next project than staff augmentation, large consultancies, and contract research organizations (CROs), is that we are not just a loose collection of individuals operating independently on our individual assignments nor are we forced together because we’re all under the same company umbrella where someone else decides the team composition and what we’ll be working on. We are, in fact, the opposite – we choose to combine our strengths because we complement each other so well, we enjoy working together, and we value the same things: QUALITY work and relationships, INTEGRITY in our business dealings, and CARE to truly invest ourselves in service to our clients.
Not only are Regulus teams efficient and high functioning, but there is also a level of trust and mutual respect between these partners that is often not even seen among in-house teams. The Founder, Tracy Janus, is a hands-on project leader and champion who is embedded into every Regulus team, ensuring continuity and consistency in business practices, fostering strong and productive relationships, and ensuring the highest standards of quality for all deliverables. In addition to the aforementioned benefits of efficiencies and quality, this business model also offers scalability in any and all directions and enables Regulus to keep overhead expenses low so that we can continue to offer our clients modest pricing for industry’s top talent.
Whether in reaction to external forces, new data becoming available, or in-house priority shifts, we know it’s common for project needs to evolve over time. Regulus is your steady and reliable partner through all of the twists, turns, accelerations, and slowdowns, committing to remain nimble and shift support where, when, and how needs dictate. We also ensure you have your same Regulus team throughout your project’s lifecycle, and that you will see them again for the next one, because we recognize the importance of stability and consistency, and that the loss of an established team member, especially those in key positions, has negative consequences such as loss of tacit knowledge, learning curves for replacement members, and disruptions to team dynamics. We want to avoid this just as much as you do.
Founder & Principal Consultant
Regulus CMC, LLC
Tracy Janus’ career trajectory from a third-shift lab technician supporting herself through school to Senior Vice President of Regulatory Affairs & CMC at a top regulatory consulting firm showcases an extraordinary blend of perseverance, expertise, and leadership in the biotech sector. With over 25 years of experience in regulatory affairs, CMC, and team leadership, Tracy is a highly capable, results-driven professional who excels in delivering exceptional service and building effective collaborations. At Regulus, she ensures that every client is truly heard and that their needs are met with precision, providing tailored support that enables the successful achievement of their development objectives.
Tracy’s regulatory career spans a wide array of modalities, including mAbs, ADCs, vaccines, cell & gene therapies, and live biotherapeutics. She has also served as Global Regulatory Lead (GRL) for both early- and late-stage programs, and as project or portfolio manager for single assets, entire divisions, and for joint ventures. Tracy has been instrumental in securing approval for 12 BLAs (so far) and their companion OUS applications, as well as hundreds of regulatory milestones across the product lifecycle. Her leadership has been key in driving successful agency meetings, development submissions, pre-approval inspections, and post-approval changes. Tracy Janus is a trusted, results-oriented leader who will ensure that your regulatory needs are expertly managed every step of the way.
At Regulus CMC, our mission is to provide tailored regulatory solutions that recognize the individuality of each client and project. Through a commitment to Quality, Integrity, and Care, we turn our clients’ ideas into action, providing the guidance and expertise needed to bring their vision to life and achieve lasting success.
Quality is the cornerstone of everything we do. It means delivering precision, compliance, and excellence at every turn. As a core value, it drives our commitment to uphold the highest standards, fostering trust, and delivering results that exceed expectations.
Integrity means upholding the highest ethical standards, being transparent, and always acting in the best interest of our clients. As a core value, it ensures that every decision we make is grounded in honesty and accountability. This commitment to Integrity fosters trust, providing our clients with the confidence that we will consistently deliver reliable, compliant, and successful regulatory solutions.
Caring means truly investing in the needs and goals of our clients, ensuring they feel supported and understood throughout every phase of the collaboration. We deliver thoughtful, personalized solutions with attention to detail, giving each project the dedicated focus it deserves. As a core value, it ensures that we not only meet expectations but also build long-lasting partnerships rooted in trust and exceptional service.
Reach out today and let’s see what we can accomplish together!
