Safety Writing | Elevating Safety Standards Across Medicinal Products and Medical Devices

Embrace the Power of Safety this February with Asphalion’s PV-month!

Embrace the Power of Safety this February with Asphalion’s PV-month!
February 8, 2024

At Asphalion, we are dedicated to ensuring the utmost safety. Our seasoned team of Pharmacovigilance (PV) brings a wealth of expertise in crafting high-quality safety documents that fulfil global regulatory requirements, spanning both medicinal products and medical devices.


In an era where regulatory scrutiny is at its peak, our commitment to excellence remains unwavering. Whether it’s the development of pharmaceuticals or the innovation of medical devices, our team is well-versed in compiling and updating essential safety documents to navigate the complexities of regulatory compliance seamlessly.


From the clinical development phase throughout the post-marketing one, we integrate safety at every stage of the product lifecycle. Our comprehensive support encompasses Annual Safety Report (ASR), Clinical Investigation report, and Periodic Safety Update Report (PSUR) , among others.


Have a look at the document to see what we can do for you to uphold the highest standards of safety and compliance! SAFETY WRITING THROUGH PRODUCT LIFECYCLE


Contact us for further information:

Search News & Events

  • Filter by category


Related news and events

EVENT | 20th Biosimilar Medicines Conference by MFE

During these two interactive days, actors of the healthcare community alongside world experts in biosimilar medicines will gather and debate the evolving biosimilar medicines landscape and emerging trends. Discussion will focus on sharing good practices and setting collective aims to achieve the depth, breadth and speed of the use of biosimilar medicines as a lever to untap their transformative value.

NEWS | New Insight on the Implementation of MDR Article 17

Article 17 of Regulation (EU) 2017/745 (Medical Device Regulation – MDR) regulates the reprocessing of single-use devices (SUDs) with relevance for the European Economic Area (EEA) which may only take place where permitted by national law and in accordance with this article.

New opening! | Pamplona office

At Asphalion, we are thrilled to announce the opening of our new office in Pamplona! This strategic decision reflects our commitment to being closer to

For further information

If you are interested in our services, or wish to get in touch for a general enquiry, please contact us for more information.

Fill the form and we will contact you as soon as possible.

You can also follow us on:

Schedule a Free Meeting

Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts. 

We will be happy to assist you!

Schedule a meeting