REMS Solutions

Innovative REMS strategy, program build & administration, and program management services designed 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

When you realize your drug may require a REMS program, it can add a significant layer of complication to your commercialization efforts (not to mention cost).

But, with just over 60 REMS programs for currently marketed products, it’s not something that is widely understood. There are only a handful of experts with the experience, resources, and connections to effectively evaluate options around REMS and efficiently manage programs to ensure you support safe use and maximize patient access.

The good news? Shepherd consists of some of the most experienced REMS experts on the planet, and we’re here to help.

Featured Services

REMS Strategy

When it comes to REMS programs, every drug is considered on a case-by-case basis, and there are many questions and nuances to consider. With our deep knowledge of the REMS space, including evolving FDA guidelines on REMS, REMS precedents, and REMS vendor capabilities, we’ll provide the insight and guidance you need to evaluate options while bringing added confidence to your decision-making process.

REMS Program Build & Administration

At Shepherd, we believe that manufacturers deserve consistently high-quality service and innovation in REMS operations. To make that belief a reality, we’ve moved away from the traditional REMS model so that we can offer best-in-class service and deliverables for every element of our clients’ REMS needs. Our approach to designing, building, and operating an end-to-end REMS solution—from writing the REMS documents to operating the website and contact center—allows us to build a tailored solution to meet each client and product’s unique requirements.

REMS Program Management

Shared REMS programs are a cost-effective way to manage multiple drugs that require the same REMS, whether that be from generic manufacturers who come together after a patent expiry or for a class-wide REMS program. At Shepherd, we leverage our patent-pending REMS PMO portal, combined with our white-glove approach to project management, to streamline shared REMS engagement for manufacturers and make decision-making easy.

Meet Your Team of Experts

With over 30 years of combined experience in REMS across our team, we have supported more than 20 REMS programs, including more than 10 shared REMS consortium groups. Our team has presented at major industry conferences and REMS-specific events and maintains relationships with FDA’s Division of Risk Management (DRM).

Melissa Landers

Founder & Senior Principal

Melissa brings over 20 years of management consulting experience to Two Labs, 16 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).

Laura Baloun

Account Director

Laura has over 25 years of healthcare experience, with 10 years in REMS. As an Account Director at Two Labs, Laura works with pharma companies to design, implement and execute best-in-class REMS and patient support programs with the goal of increasing safe use conditions for patients and commercialization success.

Lauren Long

Senior Manager

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.

What can we help you with today?

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.