REMS & RMP Support

A REMS (Risk Evaluation and Mitigation Strategy) or RMP (Risk Management Plan) is a critical safety program mandated by regulatory authorities to manage the risks associated with specific medications.

Customer service professional in a contact center wearing headset asking a coworker-a-question

These programs ensure that patient access to necessary drugs while minimizing potential harm. REMS or RMP focuses on preventing, monitoring, and managing a specific serious risk by informing, educating, and reinforcing actions to reduce the likelihood and severity of adverse events. These programs reinforce safe medication use behaviors and educate stakeholders on essential precautions. ProPharma's Contact Center Operations support REMS and RMP programs by serving as a central point of contact for patients and healthcare providers. We offer a globally accessible REMS/RMP services in, over 40 languages, adapting to local working hours and days. Our offerings include scalability, flexibility, and customizable options to support an expanding REMS portfolio. By partnering closely with our clients, we share best practices driving both innovation and efficiency. We are committed to service advancements through the use of technologies such as workforce management tools, digital communication channels (including chatbots and live chat), customer satisfaction surveys after calls, and automated line testing.

Medical Information icon

Inquiry Support

Inquiry Support

Document search icon

Product Access and Information

Product Access and Information

Decentralized Clinical Trials icon

Adverse Event (AE) Management

Adverse Event (AE) Management

Medical writing icon

Training and Education

Training and Education

Inquiry Support

  • Global Availability: ProPharma operates globally, offering support in all supported languages and aligning with local time zones.
  • Multi-Channel Platforms: Provides assistance across various regions through phone, chat, email and other communication channels.
  • Expert Management: Handles specific inquiries from healthcare providers and patients regarding risk management and minimization measures.
  • Informed Decision-Making: Facilitates informed decision-making for healthcare providers.
  • Comprehensive Resources: Maintains a repository of response documents and a comprehensive database of all submitted inquiries.
  • Regular Reporting: Ensures consistent and detailed reporting.
  • Compliance and Cultural Sensitivity: Complies with local legislation and adheres to local customs and cultures.
Confident worker woman looking at camera

Product Access and Information

  • Critical Product Access Information: Provides essential information to ensure access to critical products.
  • Efficient Dissemination: Streamlines the distribution of RMP materials, both electronically and in hard copy.
  • Pharmacy and Program Locator: Help locate pharmacies and programs that support access to REMS-required medications for patients.
  • Patient Support: We offer assistance to patients facing financial or access barriers.
Several business professionals having fun at a business meeting

Adverse Event (AE) Management

  • Adverse Event Identification and Intake: Our experienced team efficiently identifies and intakes adverse events. Specific REMS questionnaire can be completed at intake.
  • Rapid Response: Quickly Identify and respond to safety concerns notifying these immediately to the client.
  • Accurate Triage: Ensure precise triage and effective communication with relevant teams.
  • Expedited Reporting: Adheres to accelerated  AE reporting timelines.
  • Post-AE Follow-Up: Conducts thorough follow-up after adverse events in the local language either in writing or via telephone.
Business professionals smiling at a desk reviewing data

Training and Education

  • Educational Material Provision: Distributes educational materials to patients, including brochures, guides, and alert cards.
  • Up-to-Date Information: Keeps healthcare providers and patients informed on the latest risk management strategies and guidelines.
  • Compliance Reminders: Provides reminders and information on best practices to ensure compliance.
  • Certification Verification: Evaluates and verifies healthcare providers’ certification in REMS or RMP.
  • Educational Session Support: Facilitates registration and follow-up for educational sessions.
Row of professionals working at a conference table

Our REMS and RMP Experts

  • Valerie Huh Bio Photo

    Valerie Huh

    Director, Global Innovation and Implementation

    View Bio

  • Ana Ming Bio Photo

    Ana Ming

    Senior Global Innovation and Implementation Manager

    View Bio

Valerie Huh brings over 20 years of experience in the pharmaceutical and healthcare industries, with expertise in global operations and process improvements. She holds a Doctor of Pharmacy (Pharm.D.), a degree in Chemistry, and an MBA with a certificate in business analytics. In her current role, she leads innovation and technology enablement in Medical Information and supports business expansions, driving forward strategic initiatives to enhance service quality and operational efficiency.

Ana Ming is a highly skilled pharmacist based in Australia, with 12+ years of experience in the pharmaceutical services and healthcare industries. Currently at ProPharma, she brings expertise in medical information management, patient care, and regulatory compliance. Additionally, Ana is a certified Justice of the Peace (JP), combining her healthcare experience with a commitment to community service and ethical leadership. Her collaborative approach, coupled with a focus on innovative solutions, makes her a valuable asset in optimizing patient outcomes and advancing pharmaceutical practices.

REMS & RMP Contact Center Support

Ensure safe medication practices and minimize risks with ProPharma’s REMS/RMP support services. Our globally accessible solutions provide expert assistance to patients and healthcare providers in over 40 languages, enhancing risk management through informed decisions and reliable communication channels.

News & Insights

AI in PV Surveillance: Aligning Innovation with Regulatory Expectations

February 2, 2026

AI in PV Surveillance: Aligning Innovation with Regulatory Expectations

Explore how AI is transforming pharmacovigilance while ensuring patient safety, data integrity, and regulatory compliance with insights from the 2025 CIOMS report.

Preparing for eCTD 4.0: What FDA Submitters Need to Know

January 29, 2026

Preparing for eCTD 4.0: What FDA Submitters Need to Know

eCTD 4.0 is coming. Learn what’s changing, why early planning matters, and how FDA submitters can prepare for a smooth transition.

Elevating Laboratory Compliance in 2026: How Pharma & Biotech Navigate GLP, Outsourcing, and Quality Assurance

January 26, 2026

Elevating Laboratory Compliance in 2026: How Pharma & Biotech Navigate GLP, Outs...

Discover how pharmaceutical and biotech companies can elevate laboratory compliance in 2026 through GLP, strategic outsourcing, and robust quality assurance.

ProPharma Sets the Gold Standard in Sustainability with SBTi-Approved Net-Zero Targets

January 27, 2026

ProPharma Sets the Gold Standard in Sustainability with SBTi-Approved Net-Zero T...

ProPharma’s greenhouse gas reduction targets are validated by SBTi, aligning with the Net-Zero Standard and a commitment to reach net-zero by 2050.

ProPharma Expands Operations with New Office in Hyderabad

December 11, 2025

ProPharma Expands Operations with New Office in Hyderabad

ProPharma expands with a new office in Hyderabad, enhancing innovation and growth in regulatory, clinical, and compliance services for the life sciences industry.

ProPharma Welcomes Dan Ryan as President of Clinical Research Solutions

December 4, 2025

ProPharma Welcomes Dan Ryan as President of Clinical Research Solutions

ProPharma taps Daniel Ryan as President of Clinical Research Solutions, strengthening its clinical trial management leadership and expanding its FSP Solutions.

ProPharma Recognized for AI Excellence at ECCCSA

January 31, 2025

ProPharma Recognized for AI Excellence at ECCCSA

ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

October 9, 2024

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

ProPharma wins CPHI Pharma Award for excellence in regulatory and compliance innovation, enhancing efficiency and accelerating market access for life-saving therapies.

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

September 24, 2024

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

ProPharma honored with Clinical Trials Excellence Award 2024, recognizing their outstanding contributions in the pharmaceutical industry.

Case Study Setting up a Global PV System - ProPharma

February 5, 2026

Setting up a Global PV System

A company needed to rapidly establish a fully compliant global pharmacovigilance (PV) system, including UK/EU QPPV coverage, to meet regulatory requirements by a fixed deadline. With safety data and...

Case Study High-Volume Global Pharmacovigilance Onboarding - ProPharma

January 30, 2026

High-Volume Global Pharmacovigilance Onboarding

A global biotechnology sponsor faced a sudden surge in pharmacovigilance demand, with monthly ICSR volumes exceeding 30,000 cases across multiple regions. Limited internal capacity, tight onboarding...

Case Study Stabilizing High-Volume Legal Case Processing Through Structured Governance - ProPharma

January 28, 2026

Stabilizing High-Volume Legal Case Processing Through Structured Governance

ProPharma’s client faced escalating operational risk as high-volume legal case documentation overwhelmed their prior vendor. Thousands of documents, missed regulatory timelines, and a surge of...

Mastering the PSMF: The Pillar of Inspection Readiness for MAHs, LPPVs & QPPVs

March 12, 2026

Mastering the PSMF: The Pillar of Inspection Readiness for MAHs, LPPVs & QPPVs

Uncover the intricacies of Pharmacovigilance System Master File (PSMF) management and explore proven strategies to ensure inspection readiness, effective MAH oversight, and regulatory compliance...

Evolving FDA Expectations: How High-Functioning MLR Teams Manage Risk in 2026

February 17, 2026

Evolving FDA Expectations: How High-Functioning MLR Teams Manage Risk in 2026

With promotional scrutiny increasing around areas such as social media, influencer campaigns, direct-to-consumer (DTC) messaging, and data-driven claims, the session walks through the characteristics...

Scaling High-Quality Medical Information Through Offshoring

February 11, 2026

Scaling High-Quality Medical Information Through Offshoring

Navigate the complexities of offshoring Medical Information and explore proven strategies to ensure consistent quality, regulatory compliance, and seamless global execution. Join us for an...

News & Insights

AI in PV Surveillance: Aligning Innovation with Regulatory Expectations

February 2, 2026

AI in PV Surveillance: Aligning Innovation with Regulatory Expectations

Explore how AI is transforming pharmacovigilance while ensuring patient safety, data integrity, and regulatory compliance with insights from the 2025 CIOMS report.

Preparing for eCTD 4.0: What FDA Submitters Need to Know

January 29, 2026

Preparing for eCTD 4.0: What FDA Submitters Need to Know

eCTD 4.0 is coming. Learn what’s changing, why early planning matters, and how FDA submitters can prepare for a smooth transition.

Elevating Laboratory Compliance in 2026: How Pharma & Biotech Navigate GLP, Outsourcing, and Quality Assurance

January 26, 2026

Elevating Laboratory Compliance in 2026: How Pharma & Biotech Navigate GLP, Outs...

Discover how pharmaceutical and biotech companies can elevate laboratory compliance in 2026 through GLP, strategic outsourcing, and robust quality assurance.

Previous Post Arrow Next Post Arrow
ProPharma Sets the Gold Standard in Sustainability with SBTi-Approved Net-Zero Targets

January 27, 2026

ProPharma Sets the Gold Standard in Sustainability with SBTi-Approved Net-Zero T...

ProPharma’s greenhouse gas reduction targets are validated by SBTi, aligning with the Net-Zero Standard and a commitment to reach net-zero by 2050.

ProPharma Expands Operations with New Office in Hyderabad

December 11, 2025

ProPharma Expands Operations with New Office in Hyderabad

ProPharma expands with a new office in Hyderabad, enhancing innovation and growth in regulatory, clinical, and compliance services for the life sciences industry.

ProPharma Welcomes Dan Ryan as President of Clinical Research Solutions

December 4, 2025

ProPharma Welcomes Dan Ryan as President of Clinical Research Solutions

ProPharma taps Daniel Ryan as President of Clinical Research Solutions, strengthening its clinical trial management leadership and expanding its FSP Solutions.

Previous Post Arrow Next Post Arrow
ProPharma Recognized for AI Excellence at ECCCSA

January 31, 2025

ProPharma Recognized for AI Excellence at ECCCSA

ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

October 9, 2024

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

ProPharma wins CPHI Pharma Award for excellence in regulatory and compliance innovation, enhancing efficiency and accelerating market access for life-saving therapies.

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

September 24, 2024

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

ProPharma honored with Clinical Trials Excellence Award 2024, recognizing their outstanding contributions in the pharmaceutical industry.

Previous Award Arrow Next Award Arrow
Case Study Setting up a Global PV System - ProPharma

February 5, 2026

Setting up a Global PV System

A company needed to rapidly establish a fully compliant global pharmacovigilance (PV) system, including UK/EU QPPV coverage, to meet regulatory requirements by a fixed deadline. With safety data and...

Case Study High-Volume Global Pharmacovigilance Onboarding - ProPharma

January 30, 2026

High-Volume Global Pharmacovigilance Onboarding

A global biotechnology sponsor faced a sudden surge in pharmacovigilance demand, with monthly ICSR volumes exceeding 30,000 cases across multiple regions. Limited internal capacity, tight onboarding...

Case Study Stabilizing High-Volume Legal Case Processing Through Structured Governance - ProPharma

January 28, 2026

Stabilizing High-Volume Legal Case Processing Through Structured Governance

ProPharma’s client faced escalating operational risk as high-volume legal case documentation overwhelmed their prior vendor. Thousands of documents, missed regulatory timelines, and a surge of...

Previous Resource Arrow Next Resource Arrow
Mastering the PSMF: The Pillar of Inspection Readiness for MAHs, LPPVs & QPPVs

March 12, 2026

Mastering the PSMF: The Pillar of Inspection Readiness for MAHs, LPPVs & QPPVs

Uncover the intricacies of Pharmacovigilance System Master File (PSMF) management and explore proven strategies to ensure inspection readiness, effective MAH oversight, and regulatory compliance...

Evolving FDA Expectations: How High-Functioning MLR Teams Manage Risk in 2026

February 17, 2026

Evolving FDA Expectations: How High-Functioning MLR Teams Manage Risk in 2026

With promotional scrutiny increasing around areas such as social media, influencer campaigns, direct-to-consumer (DTC) messaging, and data-driven claims, the session walks through the characteristics...

Scaling High-Quality Medical Information Through Offshoring

February 11, 2026

Scaling High-Quality Medical Information Through Offshoring

Navigate the complexities of offshoring Medical Information and explore proven strategies to ensure consistent quality, regulatory compliance, and seamless global execution. Join us for an...

Previous Webinar Arrow Next Webinar Arrow