Comprehensive REMS and other post-marketing drug safety services to guide safe use and maximize access to your therapy
We’ll help you plan, implement, and manage Risk Evaluation and Mitigation Strategies (REMS) programs with confidence
Shepherd Safety Services is a specialized partner dedicated to comprehensive REMS (Risk Evaluation and Mitigation Strategies) and other post-marketing drug safety services, including RMPs (Risk Management Plans), CAPs (Controlled Access Programs), and patient registries.
At Shepherd, we believe manufacturers deserve consistently high-quality service and innovation in post-marketing safety strategy, design and operations. To make that belief a reality, we’ve moved away from the traditional post-marketing safety models offered by CROs to offer best-in-class service and deliverables for every element of our clients’ needs. Our approach combines strategic insight, operational excellence, and technology-driven solutions to create tailored programs that meet each product’s unique requirements.
We guide biopharma teams with end-to-end post-marketing safety support, grounded in evolving regulatory guidances, established precedents, and robust vendor capability insights, so you can make confident decisions and execute with precision. Our model moves beyond traditional REMS operations to deliver best‑in‑class service quality, tailored solutions, and measurable outcomes.
When it comes to drug safety, every drug is considered on a case-by-case basis, and there are many questions and nuances to consider relative to risk management and safety operations. With our deep knowledge of the REMS and drug safety space, including evolving regulatory guidelines, safety program precedents, and best practices, processes, and technologies, we’ll provide the insight and guidance you need to evaluate options while bringing added confidence to your decision-making process.
At Shepherd, we believe that manufacturers deserve consistently high-quality service and innovation in operation of REMS and other post-marketing safety programs. To make that belief a reality, we’ve moved away from the traditional CRO model so that we can offer best-in-class service and deliverables for every element of our clients’ needs. Our approach to designing, building, and operating an end-to-end safety solution—from writing the regulatory documentation to operating the website and contact center—allows us to build a tailored solution to meet each client and product’s unique requirements.
REMS and other post-marketing safety programs are complex undertakings that involve many moving parts, complex decision-making, and involvement from across a broad array of manufacturer functional areas. Our PMO HQTM technology streamlines management of both single product and shared system programs, enabling Shepherd's team to focus on strategy and service instead of manual administration of project oversight. Shepherd clients get better service and higher quality, while also having the detailed audit trails necessary for regulatory inspection readiness.
With over 40 years of combined REMS and post-marketing safety experience, the Shepherd leadership team has the knowledge and experience to create tailored solutions that meet each product’s unique risk management requirements.
Melissa brings over 25 years of management consulting experience to Two Labs, 20 in the biopharma industry. Melissa offers clients her expertise in regulatory strategy, program management, and large-scale program operations, with a particular focus on Risk Evaluation and Mitigation Strategies (REMS).
Mary brings almost 15 years of management consulting experience to Shepherd Safety Services. She offers her clients expertise in global risk management with a focus in REMS, program management for large and multi-stakeholder initiatives, and regulatory strategy, including labeling and FDA negotiations. Mary excels in facilitating complex workshops, developing training materials, and establishing governance structures.
With over 15 years of consulting experience, Lauren works closely with biopharma companies to bring high-quality solutions and practical implementation strategies to life. Lauren brings a wealth of REMS and product launch experience to every engagement, helping clients build and operate safety programs that support safe use and patient access to therapy.
No matter where you are in the process, we’re here to support, advise, and implement key strategies to ensure the success of your product.
Through every step of the commercial journey, Two Labs is your partner in driving success.
6620 Mooney Street, Suite 340
Dublin, OH 43017
Phone: (614) 389-4004
Fax: (866) 259-4324
Email: info@twolabs.com
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