Periodic Safety Update Reports (PSUR) Writing Services

Periodic Safety Update Reports (PSURs) are essential to maintaining uninterrupted access to European Union (EU) markets for medical device companies. As a core component of the EU’s post-market surveillance obligations, PSURs are a regulatory necessity for medical devices under the EU Medical Device Regulation (MDR) and for pharmaceuticals as required by the European Medicines Agency (EMA) and other regulators.

FDAQRC stands as your global regulatory partner, offering end-to-end PSUR writing services that deliver ongoing compliance and lasting peace of mind. Our seasoned consultants understand the intricacies of PSUR requirements and are committed to simplifying the path to compliance for pharma and biotech innovators in Europe and beyond.

Navigate EU PSUR Requirements With Confidence

Ensuring your organization’s compliance with EU PSUR regulations is a detail-oriented process requiring specialized expertise. Successful PSUR development involves much more than compiling safety data. Organizations must collect and synthesize information from a variety of sources and structure each report to align with the required European formats and standards.

Accurate, timely PSURs are vital to protecting your market access and supporting uninterrupted product availability in the European market. Many teams outsource these services so their in-house teams can focus on other priorities.

Our End-to-End PSUR Writing and Compilation Services

FDAQRC simplifies compliance tasks for your internal team with a comprehensive approach to PSUR writing, compilation and submission. We handle the full PSUR life cycle, so you can focus on delivering safe and effective products to market while we handle the regulatory details. Our services include:

Expert PSUR compilation and medical writing: Our specialists craft clear, compliant reports that reflect the current safety data and evolving industry standards.
Signal and risk analysis management: We evaluate the safety signals and proactively manage risk, producing reports that reflect the benefit-risk balance.
Specialized support for pharmaceuticals and medical devices: We address the unique needs of each sector with extensive support for medical device safety reporting.
Final review and on-time PSUR submission: Our team helps you prepare for regulatory review and submit PSURs on schedule.

Why Partner With FDAQRC?

Choosing FDAQRC means gaining greater regulatory confidence and organizational efficiency. Here’s what sets us apart:

A global expert network: Our team comprises over 500 vetted consultants, including former health authority officials, bringing deep insight into regulator expectations and European requirements.
Regulatory insight: With profound expertise in pharmacovigilance reporting services and unparalleled familiarity with the nuances of the European market, we deliver PSUR solutions aligned to your business and industry.
Reduced burden: By outsourcing your PSUR writing and compilation to our team, your internal staff can focus on innovation and growth while maintaining confidence in your compliance.

Secure Your Market Access in Europe

Timely and compliant PSURs are nonnegotiable for maintaining your product’s presence in the European market and safeguarding patient well-being. Let FDAQRC’s PSUR writing services secure your compliance and support the entire life cycle of your pharmaceutical or medical device products.

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