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PSMF Management.
Maintenance, QPPV provision & full PV system setup.

What is PSMF Management?

A Pharmacovigilance System Master File (PSMF) is an essential and obligatory component of pharmacovigilance compliance within the European Economic Area (EEA) in accordance with Directive 2001/83/EC.

PSMFs provide a detailed description of the pharmacovigilance system used by a Marketing Authorisation Holder (MAH) with its authorised human and veterinary medicinal products and is maintained independently from the Marketing Authorisation (MA) itself. It must be permanently available for inspection and provided within 7 days to National Competent Authorities on request.

Within the EEA, the PSMF can be kept at one of two designated locations: either where the primary pharmacovigilance activities of the MAH are carried out or where the Qualified Person for Pharmacovigilance (QPPV) operates. It’s essential to note that QPPVs are required to be based and active within the EEA.

Click for more information from the European Medicines Agency (EMA) on PSMFs.

When initiating a Marketing Authorization Application (MAA), MAHs are obligated to provide a detailed description of the pharmacovigilance system that will be in operation and fully functional at the time the application is granted, ensuring that any future plans are distinctly outlined and separated. During the evaluation process of their MAA, MA applicants may be requested to provide a copy of the PSMF for review and assessment.

Whilst there is no fixed structure for a PSMF it must follow the guidance within Good Pharmacovigilance Practices (GVP), Module II, and typically cover 6 areas:

  • Qualified person responsible for pharmacovigilance
  • Organizational structure
  • Computer system
  • PV processes
  • Quality system activities
  • Delegated activities

Click for more information from the EMA on GVP Module II.

Why use Aegisana’s PSMF Management services?

Full compliance.

Aegisana’s Pharmacovigilance team have extensive experience managing client PSMFs and all the day-to-day updates and maintenance required.

We can design and implement your entire Global PV System and how it interacts with Regulatory and Quality functions, provide qualified QPPVs and all LPPV & Local Safety Personnel including any Local PSMF requirements, across multiple countries and authorities.

Reliable and competent.

We want you to have complete peace of mind that your system is fully compliant and inspection ready, through our trademark efficient and competent delivery.

However complex your requirements, we are ready to provide the perfect turnkey pharmacovigilance system to meet them.

"Professional excellence from a great team highly experienced in different areas of the business such as pharmaceuticals, cosmetics, etc. and with extensive knowledge in the activities offered."
Belén SegarraRegulatory Affairs Head / Technical Director, Qualix Pharma.
"Aegisana not only meets, but exceeds the highest standards in Pharmacovigilance services, which is exactly what we have received. Their commitment to excellence is evident in every aspect of their work."
Alfonso Lomas Pharmacovigilance Activity Coordinator, Mana Pharma.
"Aegisana is an innovative, reliable company with which we have achieved 100% results. I would like to highlight their professionalism, availability, and efficiency, as well as their exceptional communication. We have a close relationship that creates real teamwork."
José Manuel de la Torre GarcíaQualified Person & Regulatory Affairs Manager, Tora Laboratories.
"Moving to Aegisana is a change that Qualix Pharma opted for years ago and they have more than met our expectations."
Belén SegarraRegulatory Affairs Head / Technical Director, Qualix Pharma.
“Aegisana’s technicians are highly trained experts, and their experience is invaluable for all our Pharmaceutical projects."
Alfonso Lomas Pharmacovigilance Activity Coordinator, Mana Pharma.
"We have been working with the team at Aegisana since its inception and it has been a great success. Pharmacovigilance is clearly a passion at Aegisana, and I cannot recommend a better partner to entrust your project requirements to. You are safe in their hands."
Sergio ArroyoLaboratory Director, Netpharmalab Consulting Services.
"In this sector, after years of experience, it is not easy to find a company that offers this type of service at such a high level, involving security, ease of management and communication, and optimization of work for the subcontracting company."
Belén SegarraRegulatory Affairs Head / Technical Director, Qualix Pharma.
“Working with Aegisana is super easy! They adapt to the needs and resources of our company 100%. They helped us update our PV department due to the change in legislation and the experience was fantastic."
Almudena Pradera DVM PhDChief Scientific Officer, EquiCord.
"A team very involved and responsible in every task developed and service provided. Excellent communication with quick advice and response."
Belén SegarraRegulatory Affairs Head / Technical Director, Qualix Pharma.
"The Aegisana team are experts in everything related to pharmacovigilance, giving us confidence and peace of mind. We work with them as a partner as if they were an internal company department."
Marta ManzanaresRegulatory Affairs, Quality Assurance & Pharmacovigilance Manager, Adamed.

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