Our Capabilities

We'll Help You Navigate Every Detail

Whether you are just starting to explore a REMS program, collaborating with the FDA, or seeking expert guidance for an existing program, our experienced team will help you navigate REMS guidelines to eliminate patient access barriers and ensure a positive enrollee experience. 

As our partner, you will feel confident in our programs, shaped by decades of real-world REMS experience where we honed our skills working with the FDA to create REMS Supporting Documents and REMS required pre-approval materials.   

The Expertise You're Looking For

  • Dedicated Support: Our team is here to ensure seamless patient care and program compliance. Reach us anytime via our dedicated phone line, and enjoy 24/7 pharmacist assistance.
  • Clear Communication: We maintain open lines with patients, prescribers, pharmacies, and pharmaceutical partners, ensuring everyone is informed and connected.
  • Comprehensive Guidance: We provide all the necessary support for enrollments and program requirements, specializing in audits and coordinating surveys to meet REMS standards.
  • Tailored Engagement: From day one, we collaborate with manufacturers to create customized programs that align with REMS requirements, ensuring accurate reporting and effective operations.

 

Our Keys to Success

Achieving success in a REMS program involves several components, including engagement with patients/caregivers, prescribers, pharmacies/distributors, and healthcare settings, tailored to the program's complexity. Our strategy focuses on collaborative engagement, personalized solutions, and extensive expertise, ensuring we are a dedicated partner capable of meeting all your REMS requirements effectively.

Pre-launch preparation and post-launch activity with highly collaborative cross-functional teams.

Strong, accurate assessments for detailed, periodic FDA reporting.

21 CFR compliant technology capabilities for data and reporting compliance in line with FDA requirements.

Restricted distribution network and HCPs who are educated on the guidelines of the REMS Program.

Willingness to work with FDA on guidelines and potential REMS updates for shared goal of patient safety.

Accurate and complete REMS Program documentation for compliance and audit preparedness.