Risk Evaluation and Mitigation Strategy (REMS) Program

REMS Program Audits: Ensuring Safety and Compliance

The Risk Evaluation and Mitigation Strategy (REMS) Program is a critical initiative by the U.S. FDA to ensure the benefits of certain medications outweigh their risks.

For medications that come with serious safety concerns, adherence to REMS requirements is essential. Rephine’s REMS audits provide the assurance you need to meet these requirements effectively.

Rephine delivers specialised REMS audits to pharmacies and healthcare facilities in the USA, ensuring full compliance with FDA requirements.

Our audits go beyond GMP evaluations to focus on key aspects of REMS compliance, including:

Certification of prescribers, dispensers, and healthcare facilities.

Registry and tracking system evaluations.

Monitoring compliance and following up on Corrective and Preventive Actions (CAPA).

How Rephine Can Help

Rephine’s global team of experienced consultants offers tailored support to simplify REMS compliance:

Efficient Auditing: Conducting audits at scale to ensure comprehensive oversight.
CAPA Management: Providing guidance on CAPA planning and follow-up.
Program Management: Managing extensive audit schedules for large REMS product portfolios.

Guide: Partnering with a leading European pharmaceutical manufacturer, Rephine successfully completed 125 REMS audits in one year, ensuring strict adherence to FDA guidelines.

Why Choose Rephine?

With a proven track record in REMS compliance and a global team of experts, Rephine ensures:

Scalable audit capabilities.
Adherence to stringent FDA guidelines.
Streamlined processes for pharmacies, healthcare facilities, and manufacturers.

Need to discuss about a project? We are only one discovery call away.

Ensure your REMS compliance with Rephine’s trusted audit services. We offer free 30 minute discovery calls so we can understand your QA requirements for any project. Whether you're just starting out, or an established enterprise, we've got you covered.

The team at Rephine are incredibly professional. There’s no one we would trust in the same way with something as fundamental as the final quality of our product - and everything that has gone into it. It isn’t just that the Rephine team have all the right people in all the right places; it’s also that they’re also so deeply embedded in the regulatory environment that they always know what’s coming next, as well as what’s needed today.”

Where do you Need our Help?

For GMP Auditing, Quality Assurance & Digitalisation, we’re the partner of choice for all the stakeholders we deal with.

We provide extensive GMP consulting services to help keep our clients ahead of the needs and expectations of regulators.

Global Audit Library

Explore our extensive GMP audit library to see the range and scope of live reports we have in stock, join a live audit, or commission a bespoke audit

GMP Audit Services

Maintain high standards of life sciences manufacturing supplier qualifications and GMP auditing within the supply chain through our expertise

GxP Consultancy

Discover how we can help your product reach to market, fully and demonstrably complying with the latest GxP standards

Digitalisation

From data integrity to implementing new systems, our experienced team with a digital mindset, can lead you to transformative achievements

Related Resources

Ensuring Compliance and Data Integrity in Pharmacovigilan

CAPA

Strengthening CAPA & Exceptions Management

Learn how Rephine’s tailored GxP training helped a pharmaceutical manufacturer strengthen CAPA effectiveness, improve compliance, and boost team confidence.

Blog

EU GMP Annex 1 vs FDA Aseptic Guide: Bridging Compliance

EU and U.S. regulators share the same sterility assurance goals, but their approaches differ. Learn how to align Annex 1 and FDA guidance to streamline ...

Case Study

QMS Implementation for Cannabis Manufacturer

Discover how Rephine helped a new cannabis API manufacturer design and implement a compliant QMS, enabling GMP authorisation and audit readiness.

Blog

GMP & GDP: Ensuring Quality in Drug Storage and Transport

Storage and transport aren’t just logistics — they’re critical GMP processes. Discover how USP helps pharma companies manage risk and maintain quality across global ...

Rephine partners with Scilife to deliver stronger digital quality and compliance solutions

Company News

Rephine Partners with Scilife to Strengthen Digital Quality and Compliance Solutions

Rephine has announced a new partnership with Scilife, a leading Smart Quality Management platform provider. By joining forces, the two companies will deliver stronger compliance ...

Blog

Blockchain for GMP Documentation: Hype or Future Reality?

Blockchain promises immutability, traceability, and transparency for GMP documentation. But is it a compliance game-changer — or just hype?

Guide

Is Your Insurance Policy Ready for the New EU Product Liability Directive?

The EU’s new Product Liability Directive (2024/2853) changes who can be held liable and what damages can be claimed. From software and data loss to ...

News update: 100% drug tariffs in the USA impacting pharmaceutical supply chains and compliance

Article

100% Drug Tariffs in the U.S. – Impact on Pharma Supply Chains & Compliance

The U.S. has announced sweeping 100% tariffs on patented medicines, disrupting pharma supply chains and market access. Discover what this means for manufacturers — and ...

Blog

Data Governance & AI in Pharma | Ensuring Trust & Compliance

In an age where AI promises transformation across pharma, success hinges on one factor: data you can trust. Explore how rigorous governance, quality control, and ...

Let's get in touch

Please get in touch. Our expert GMP audit team is only a click away, on standby to answer all your questions.

Email: [email protected]

Social:

REPHINE HQ

Stevenage, UK
+44 1763 853135

REPHINE BARCELONA S.L.U

Barcelona, Spain
+34 934 178065

REPHINE CHINA

Shanghai, China

REPHINE INDIA

Hyderabad, India

First Name

Last Name

Phone

Country

Company

Job Title

Interested In

Message

Marketing Opt In

Rephine respects your privacy. Choosing to check the box means that you agree to the Rephine Privacy Policy. You can unsubscribe at any time.

GMP Audit Services

GxP Consultancy

Risk Evaluation and Mitigation Strategy (REMS) Program

REMS Program Audits: Ensuring Safety and Compliance

The Risk Evaluation and Mitigation Strategy (REMS) Program is a critical initiative by the U.S. FDA to ensure the benefits of certain medications outweigh their risks.

Certification of prescribers, dispensers, and healthcare facilities.

Registry and tracking system evaluations.

Monitoring compliance and following up on Corrective and Preventive Actions (CAPA).

How Rephine Can Help

Rephine’s global team of experienced consultants offers tailored support to simplify REMS compliance:

Why Choose Rephine?

Need to discuss about a project? We are only one discovery call away.

Ensure your REMS compliance with Rephine’s trusted audit services. We offer free 30 minute discovery calls so we can understand your QA requirements for any project. Whether you're just starting out, or an established enterprise, we've got you covered.

Where do you Need our Help?

For GMP Auditing, Quality Assurance & Digitalisation, we’re the partner of choice for all the stakeholders we deal with.

Global Audit Library

GMP Audit Services

GxP Consultancy

Digitalisation

Related Resources

Let's get in touch

Strengthen Your Assurance Journey