About

MS Pharm is a company established by experienced experts with a view to setting the standards and providing the highest level of services.  It enjoys extensive experience in pharmacovigilance and its own team of experienced reviewers and experts (physicians, pharmacists) – many of them gained their knowledge working for many years in global pharmaceutical companies. The MS Pharm experience comes also from a series of audits and inspections carried out in the company.

MS Pharm domain is the monitoring of medical literature in terms of pharmacovigilance and local pharmacovigilance support in Europe, CIS, Middle and Far East countries (eg. Vietnam) based on knowledge of local national pharmacovigilance requirements in individual countries – we work with local experts in pharmacovigilance.

The top quality of our processes, quality management system and their compliance with GVP requirements is confirmed by an independent Certificate of compliance.

We are focused on local medical literature monitoring and local pharmacovigilance services across the Europe and CIS countries.

Our advantages are:

  • extensive experience (collectively, over 300 years of experience in pharmacovigilance)
  • own team of local reviewers and experts (physicians, pharmacists)
  • knowledge of local pharmacovigilance requirements
  • regular quality control of all processes
  • own validated tools that allow to automate the processes

Our goal is to become a leader in medical literature monitoring and set standards in this area. We aim to be a partner you can rely on.

Medical literature monitoring

Thanks to automated processes, validated tools and our own team of over 40 experienced reviewers (physicians, pharmacists), we provide a full range of relevant information on pharmacovigilance from literature sources.

We provide:

Local literature monitoring

We monitor over 850 local medical, pharmaceutical and veterinary journals on an ongoing basis. Publications – mostly not indexed in global databases – are analyzed in over 40 countries. Our current range of services is:

  • Bulgaria, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Slovakia
  • Austria, Belgium, Cyprus, Germany, Greece, Finland, France, Iceland, Italy, Liechtenstein, Luxembourg, Malta, the Netherlands, Norway, Portugal, Spain, Sweden, Switzerland
  • Albania, Bosnia and Herzegovina, Croatia, Macedonia, Montenegro, Serbia, Slovenia
  • Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Mongolia, Russia, Tajikistan, Turkmenistan, Ukraine, Uzbekistan
  • Israel, Tunisia, Turkey, Vietnam, United Arab Emirates

 

Access to the full content of all journals, analysis of each article by an experienced expert, targeting monitoring targeted for the purposes of pharmacovigilance and the implemented quality management system ensure that MS Pharm providing a report containing all the necessary information is a partner you can rely on.

Monitoring of medical literature is fully in line with the GVP Guidelines and local regulations, which has been confirmed by an independent certification audit and obtained Certificate of GVP compliance.

The basic scope of the service comprises:

    • a report containing detailed information on the subject
      • substance/product – name, form, dose, route of administration
      • patient – initials, age or age group, gender
      • type of event or special situation – AE, SAE, ADR, SADR, off-label, pregnancy, etc.
      • country of the event
      • a brief description of the case in local language and English
    • providing publications containing information subject to reporting within 24 hours of identification of information (safety report)
    • weekly or monthly reports (reconciliation)
    • regular update of the journal list

In order to be able to assess the scope and quality of our services yourself, we offer a free monthly trial period during which you make use of the reports submitted by MS Pharm to the full extent. We want you to consciously choose MS Pharm as a partner you can rely on after this trial.

Global Literature Monitoring

Having access to global medical databases we provide monitoring of indexed literature sources.

We analyze each publication in terms of pharmacovigilance and the country of origin, the name of the medicinal product, its form and route of administration, specific risk areas for each product, while our dedicated application automatically sends safety reports (within 24h), generates summary reports and records the entire process.

The added value of our services is the classification of the obtained results on ICSR, information relevant for signal detection and PSURs with respective justification. A summary report in a structured format (Excel) allows better sorting, filtering and archiving. MS Pharm is a partner, you can realy on.

Local pharmacovigilance support

In cooperation with experienced partner, Vigi Wings, we provide the services of a local pharmacovigilance support across Europe, the CIS countries, the Middle and Far East (eg. Vietnam).

In accordance with local requirements, we provide nomination of a local contact persons for pharmacovigilance (LPPV) with 24/7 availability, submitting notifications, processing of AE/Other reportable information reports, information on local legal requirements and changes, monitoring of local medical literature and monthly reports.

We provide the service of a local pharmacovigilance support in the following countries:

  • Bulgaria, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Slovakia
  • Austria, Belgium, Cyprus, Greece, Finland, France, Germany, Iceland, Italy, Liechtenstein, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland
  • Albania, Bosnia and Herzegovina, Croatia, Macedonia, Montenegro, Slovenia, Serbia
  • Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Mongolia, Russian Federation, Tajikistan, Turkmenistan, Ukraine, Uzbekistan
  • Israel, Tunisia, Turkey, United Urab Emirates, Vietnam

MEDICINES COMPLETE

MedicinesComplete is the knowledge of hundreds of experts, scientists and researchers available at your fingertips. Check out the most reliable publications in the world.

The key MedicinesComplete compendia:

A full list of compendia with detailed information is available here.

The publisher of MedicinesComplete is Pharmaceutical Press, a publishing house of the Royal Pharmaceutical Society of Great Britain. MS Pharm as a partner you can rely on is an authorized representative for MedicinesComplete.

Medical writing

We are ready to provide the full range of required regulatory documents and expert reports. Using our wide range of experts and specialists, we will be happy to prepare:

  • Expert Report and Opinion
  • Risk Management Plan
  • Addendum to Clinical Overview
  • Periodic Benefit-Risk Evaluation Report
  • Periodic Safety Update Report
  • Development Safety Update Report

We provide support throughout the entire process of collating documentation and communication with the competent authorities.

Contacts

Company headquarters:

MS Pharm s.r.o.
Olšanská 55/5
130 00 Prague 3
Czech Republic

Company ID: 04489918
EU VAT: CZ04489918

web: www.mspharm.eu
e-mail: info@mspharm.eu

Contact person:

Marek Bielski
Business Development Manager

t. +48 602 761 141
e. office@mspharm.eu

Address for correspondence:

MS Pharm s.r.o.
Olšanská 55/5
130 00 Prague 3
Czech Republic