Does your Molecule need a PSUR in 2026?
Comply on time, without errors, and effortlessly.
Outsource your PSUR Management with complete confidence
We guarantee your regulatory compliance with an expert service powered by AI technology.
Effortless. Error-free. On time.
Marketing Authorisation Holders (MAHs) are required to periodically submit Periodic Safety Update Reports (PSURs) for their authorised molecules. At Asphalion, we specialize in the end-to-end management of this critical regulatory requirement.
Our comprehensive service is built on four fundamental pillars that serve as your greatest guarantee:
- 25 years of regulatory experience and a deep understanding of pharmacovigilance.
- Expert multidisciplinary team including Medical Doctors, PhDs, and senior medical writers.
- Proprietary technology that reduces errors, accelerates critical tasks, and ensures document consistency.
- Audited and certified quality under ISO 9001 and ISO 13485 standards.
Leave the management in expert hands and ensure you comply without complications:
Plan Your PSURs
Have questions about your specific case? Use our interactive planner and anticipate your 2026 obligations.
User Instructions
- Start a Search
The tool offers two ways to begin:
- Search by Active Substance: Type the name or a part of the name of a molecule (e.g., “lamivu”) in the first field.
- Search by Company (MAH): Type the name or a part of the name of the marketing authorization holder (e.g., “Bay”) in the second field.
Important: Fill in only one of the two fields for the search to work correctly. Then, press the Search button.
- Follow the Guided Steps
Sometimes, your search may have several possible results. The tool will guide you to choose the correct one.
- If multiple molecules or companies are found: A list will appear. Simply select the option you are interested in and click the Continue or Show Report button to proceed.
- If a molecule belongs to several companies: After choosing the molecule, the tool will ask you to select the specific company (MAH). Choose one and click Generate Report.
- Understanding the Final Report
Once you have narrowed down your search, you will see the final report, divided into two clear sections:
Section 1: PSURs Required for 2026
- What it means: These are the records that, according to the EURD list, require the submission of a PSUR regardless of the product’s legal basis.
- What you can do: If you want a quote for managing these reports, click the Request Quote for these PSURs button. An email, ready to be sent with the data from this section, will open.
Section 2: PSUR Requirement for 2026 To Be Confirmed (Review Recommended)
- What it means: These are records that, depending on the legal basis of the product, may or may not require a standard PSUR (e.g., generics, well-established use). However, other regulatory obligations may still apply.
- What you can do: If you want an expert to review these cases, click the Request Pharmacovigilance Review button. This will generate an email with the information from this section to request a review.
Our Experience, Your Guarantee.
Our methodology, which combines expert talent with proprietary technology, is the foundation of the trust placed in us by over 1,000 clients worldwide.
✓ Over 300 PSURs and more than 100 Risk Management Plans (RMPs) successfully prepared for pharmaceutical companies in Europe and other regions.
✓ Multidisciplinary team of Medical Doctors, PhDs, and senior medical writers with over a decade of experience in the sector.
✓ Proprietary technology to accelerate literature searches, reduce data management errors, and efficiently control the entire process.
✓ ISO 9001 and ISO 13485 certifications ensuring the highest quality and security in all our projects.
Watch Our Technical Webinar!
Asphalion expert Vanesa Palau walks you through key insights for an effective PSUR preparation and shares practical approaches to leveraging digitalization and AI tools in PSURs.
Let's Talk About Your 2026 PSURs!
Our team can analyze your case and help you design a safe and efficient strategy. Leave the management in expert hands and ensure you comply without complications.
FAQs
Answers to some common questions.
How do I know if my product needs a PSUR?
The obligation to submit a PSUR depends on factors like the product’s legal basis, authorization type, approved indications, its inclusion in the EURD list, and whether it is part of an active substance combination.
🔍 To assist you, we have developed a tool that cross-references public data from the EMA. You can check it in seconds right from this page.
What happens if I don't submit a PSUR on time?
Failure to meet the deadlines established by European regulations can lead to warnings, sanctions, or even the suspension of the marketing authorisation.
🕒 At Asphalion, we manage the entire process to ensure your PSURs are submitted correctly and on time.
What does Asphalion's PSUR writing service include?
Our comprehensive service covers everything from initial planning and coordination with your team to expert writing, optimized review rounds, and the final validated submission.
✅ Everything is handled by a specialized team and supported by proprietary technology that reduces errors and accelerates each phase of the process.
Can you help me check if I am exempt from submitting PSURs?
Yes. While our tool provides guidance using public data, some situations require expert analysis: generic products, the legal basis of registration, specific indications, etc.
📩 You can contact us directly, and we will help you confirm if your product is exempt.
Do you work with companies outside the EU?
Yes. We collaborate with companies from all over the world on the writing and maintenance of PSURs and RMPs for European and international markets.
🌍 We adapt our service to local regulations and guide you through the entire process.
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