The services offered by Komtur Polska
cover five main areas:

Komtur CT - Clinical Trials

This includes extensive logistical and other services associated with clinical trials, such as:

  • comparator sourcing
  • procurement of sample packages
  • procurement of medical devices and medical aids
  • depot management
  • labeling and various other associated services
  • project management, storage at various temperature ranges, door-to-door cold chain delivery

Komtur AP - Access Programs

This includes all services associated with:

  • creating pre-marketing concepts and market launch programs prior to drug approval
  • drug imports
  • market introduction of new drugs to the Polish and foreign markets
  • extensive, highly detailed product management
  • company representation for foreign companies
  • product consignment services
  • pre-wholesale services
  • marketing and promotion for pharmaceutical products
  • registration services
  • reimbursment support

Komtur OSM - Orphan and Specialized Medications

We offer a broad service range for:

  • drug and food supplement distribution for specific medical purposes, in case of rare or extremely rare diseases
  • company representation during reimbursement processes
  • development of marketing strategies
  • company representation for public tenders
  • promotional measures

Komtur RA – Regulatory Affairs:

In Poland and throughout Europe, we offer:

  • comprehensive support at every stage of the lifecycle of medicinal products, medical devices, food supplements, and food for special medical purposes
  • handling of registration and post-registration procedures (including variations and notifications) for medicinal products
  • collaboration and assistance in communication with local Agencies and other institutions supervising the pharmaceutical market
  • monitoring of annual fees and other administrative obligations for medicinal products
  • evaluation of leaflet and packaging artwork for medicinal products to ensure compliance with applicable regulations
  • consultancy on proper labelling of medical devices and food supplements

Komtur Market access:

We offer a wide range of services related to:

  • building a comprehensive drug market entry strategy
  • marketing and promotion of pharmaceutical products
  • programs supporting the sale of medicines
  • service in the field of registration of a medicinal product
  • obtaining refunds

Komtur PV – Pharmacovigilance

We provide a full range of pharmacovigilance services – locally and across Europe:

  • implementation and maintenance of the PV system, including PSMF system documentation
  • management of adverse event reports in accordance with applicable regulations (GVP, EudraVigilance)
  • Pharmacovigilance safety monitoring – provision of a Qualified Person Responsible for Pharmacovigilance (QPPV) and a local contact person (LPPV), available 24/7, in line with the legal requirements of each country
  • monitoring of medical literature at both local and international levels
  • preparation and updating of periodic reports, Risk Management Plans, and other required documents
  • support in communication with regulatory authorities such as URPL, EMA, and other local pharmaceutical market supervisory institutions
  • Pharmacovigilance training and audits