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.

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