Global Literature Review

Maintain compliance and enhance safety oversight with expert-driven literature evaluation and reporting.

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Literature Search

The review of worldwide scientific literature is an essential part of the ongoing safety surveillance of medicinal products, regardless of commercial status. To ensure compliance with regulatory legislation worldwide, it is essential that global and local literature screening, where applicable, is regularly conducted to identify reportable ICSRs and safety relevant information.

Our experienced team at ProPharma can support you or assume full responsibility for these activities to ensure your PV program adheres to the global regulatory requirements.

In addition, our services are cost-effective, and we are able to conduct global literature surveillance of large bibliographical databases including Medline® via the Biologit platform.

We have extensive experience in developing robust search strategies for our clients and providing results from these searches according to an agreed upon periodicity. We can perform the review and assessment of identified literature articles and ensure the efficient and auditable documentation of results.

We have experience and well-established processes for conducting local literature screenings. We can support you in the set-up and conduct, including the identification of relevant local databases and journals, and translation of articles, if needed.

For Marketing Authorization Holders (MAHs) with active substances included in the EMA’s Medical Literature Monitoring (MLM) list, we perform EudraVigilance checks using the ICSR Export module based on the frequency contracted. In addition, we provide local literature searches in relevant local scientific and medical journals in countries where your product is marketed and where this is legally required.

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News & Insights

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News & Insights

Medical Information in the Netherlands: Safeguarding Compliance and Patient Confidence

October 2, 2025

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Discover how ProPharma's medical information services in the Netherlands ensure patient safety, regulatory compliance, and data privacy with expert support.

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Tips for Preparing Successful FDA 510(k) Submissions

Discover essential tips for preparing a successful FDA 510(k) submission. Learn common pitfalls to avoid, align with FDA expectations, and streamline your path to clearance.

FDA’s Crackdown on Drug Advertising: Key Lessons from 60 Compliance Letters in 2025

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FDA’s Crackdown on Drug Advertising: Key Lessons from 60 Compliance Letters in 2...

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Previous Post Arrow Next Post Arrow
ProPharma Appoints Marshall Florence, Former FDA Labeling Expert, as Vice President, Labeling & Strategy to Advance Strategic Labeling & Promotional Review

July 8, 2025

ProPharma Appoints Marshall Florence, Former FDA Labeling Expert, as Vice Presid...

ProPharma appoints former FDA labeling expert as VP, Labeling & Strategy, enhancing strategic labeling, promotional review, and regulatory consulting expertise to accelerate drug development and...

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 Appoints Brian Tuttle as Chief Financial Officer

October 21, 2024

ProPharma Appoints Brian Tuttle as Chief Financial Officer

ProPharma appoints Brian Tuttle as CFO to drive financial strategy and accelerate global growth, leveraging his 20 years of life sciences industry experience.

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 Critical Database Lock Milestone Achieved Through Rapid FSP Support for BioXcel Therapeutics, Inc. - ProPharma

October 6, 2025

Critical Database Lock Milestone Achieved Through Rapid FSP Support for BioXcel ...

When BioXcel Therapeutics’ pivotal Phase 3 study faced a critical slowdown, timelines and regulatory goals were at risk. With their primary CRO unable to meet growing demands, ProPharma stepped in —...

Whitepapers Your Complete FDA 510(k) Premarket Notification Checklist

September 30, 2025

Your Complete FDA 510(k) Premarket Notification Checklist

Step-by-step guide to navigating the FDA 510(k) submission process with confidence Submitting a 510(k) premarket notification is a critical milestone for medical device manufacturers seeking U.S....

Infographic Unannounced FDA Inspections Without Borders - ProPharma

September 19, 2025

Unannounced FDA Inspections Without Borders

Unannounced FDA inspections are no longer limited to the U.S. — they’re expanding globally. Starting in 2025, foreign sites will face the same surprise visits and public scrutiny as U.S. facilities,...

Previous Resource Arrow Next Resource Arrow
Navigating the New EU HTA Regulation as an MAH: Strategic Insights for Successful JCA Submissions

November 18, 2025

Navigating the New EU HTA Regulation as an MAH: Strategic Insights for Successful JCA Submissions

Explore how the new EU HTA Regulation (EU HTAR) is transforming market access across Europe. Join our expert to learn practical strategies for successful Joint Clinical Assessment (JCA) submissions,...

AI in Medical Information: Who Holds the Responsibility?

October 16, 2025

AI in Medical Information: Who Holds the Responsibility?

In Medical Information (MI) and beyond, key questions arise: Who ensures accuracy, compliance, and ethical use — individual contributors, leadership, pharma clients, or technology providers? And what...

Improving Patient Health and Safety through Pharmacovigilance and Medical Information Synergy

September 25, 2025

Improving Patient Health and Safety through Pharmacovigilance and Medical Information Synergy

Medical Information (MI) and Pharmacovigilance (PV) work together to protect public health by identifying and evaluating emerging safety signals. Watch our in-depth webinar, where our experts explore...

Previous Webinar Arrow Next Webinar Arrow