BEST
SOLUTIONS
BASED ON
EXPERIENCE

BEST
SOLUTIONS
BASED ON
EXPERIENCE

BEST
SOLUTIONS
BASED ON
EXPERIENCE

BEST
SOLUTIONS
BASED ON
EXPERIENCE

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REGULATORY AFFAIRS SERVICES

We offer a full range of services regarding the registration of medicinal products, medical devices and biocidal products:

  • conducting and monitoring the registration process of medicinal products to the market in the national procedure and MRP/DCP
  • local support for the registration in the Central procedure
  • audit, development and verification of registration documentation
  • conducting the process of post-registration variations, re-registration and notification
  • carrying out the “sunset clause exemption” procedure
  • preparation of the texts of the Summary of Product Characteristics (SmPC), information leaflets and packaging
  • preparation of the expert reports
  • preparation and verification of the educational materials
  • preparation and verification of the graphic designs
  • tests of the readability of the patient information leaflet
  • coordination of analytical tests of medicinal products, including tests after the first placing on the market
  • representation of Marketing Authorisation Holders (MAHs) in dealings with Polish administrative authorities: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Ministry of Health, Pharmaceutical Inspectorate, Sanitary Inspectorate and others
  • consulting concerning pharmaceutical law and local requirements
  • expert translation services: medicine and pharmacy
  • preparation of the required documentation and coordination of the reimbursement process for medicinal products, reimbursement negotiations
  • clinical trials of medicinal products
  • pharmacovigilance
  • preparation of documentation and notifications regarding medical devices and biocides

     

    and


  • preparation of documentation and notification of dietary supplements
  • preparation of documentation and notification of cosmetics.

Interested in our offer?

Contact us. Find out how we can support your business!

Together we can do more.