Dossier

KMJ pharma® Sp. z o. o. specializes in handling the process of registration of medicinal products, preparing and supervising each stage of this registration. With our long-standing experience and extensive medical and pharmaceutical knowledge, we offer our clients services related to:

  • determining registration requirements for the given type of a medicinal product (API),
  • choosing the kind of application for marketing authorization for a medicinal product:
    • a complete application - documentation containing results of preclinical and clinical studies for the given form and recommendations for a medicinal product,
    • an application regarding active substances with well-established use (WEU) - preclinical and clinical documentation based on literature data,
    • an abridged application - preclinical and clinical data are replaced with studies demonstrating the pharmaceutical equivalence of the medicine described in the application against a reference medicine,
    • a hybrid application – an application partly based on literature data and results of studies; it refers e.g. to cases where there are differences regarding the reference medicine (e.g. different power, form),
    • a "fixed combination" application - for the combination of substances previously used separately in registered medicines,
    • an "informed consent" application - based on making elements of registered product documentation available.
  • preparing expert reports and selected modules of documentation:
    • module 1
    • module 1.5.2 (Justification regarding the choice of the application category)
    • module 1.6.1 (Environmental Risk Assessment)
    • module 2.3 (Quality Overall Summary) + QES (renewal)
    • module 2.4 (Nonclinical Overview)
    • module 2.5 (Clinical Overview)
    • module 2.6 (Nonclinical Summary)
    • module 2.7 (Clinical Summary)
    • module 3 (Quality)
    • module 4 (Nonclinical Study Reports)
    • module 5 (Clinical Study Reports)
    • PSUR reports
    • clinical reports (re-registration)
    • examination of clarity of a leaflet
  • supervising processes of registration/re-registration/post-registration changes in the following procedures:
    • national
    • mutual recognition (MRP)
    • decentralized (DCP)
    • central
  • preparing documentation for type IA/IB and type IIchanges (including the preparation of an analytical part of elements of the production process),
  • preparing/translating information leaflets (a description of the medicinal product, leaflets for a patient, packaging labels) along with marking in the Braille language.