An offer tailored to your needs
Comprehensive registration services, regulatory affairs, and pharmacovigilance – we support pharmaceutical companies in effectively bringing products to market.
Regulatory affairs
Our regulatory affairs services for medicinal products cover the following regulatory activities:
Medicinal Products Registration
Our offer includes activities related to the registration of medicinal products in Poland and European Union countries within the framework of:
- National procedures
- European procedures (Mutual Recognition Procedure – MRP, Decentralised Procedure – DCP, and support in the Centralised Procedure), covering both full procedure management and coordination as well as support limited to national phases only.
Preparation and translation of product information documents (Summary of Product Characteristics, Patient Leaflet, packaging labelling) including Braille.
Coordination of leaflet readability testing (PIL readability testing, PIL user testing) in accordance with current EU and European agency guidelines.
Preparation of registration documentation and substantive evaluation of documentation regarding future registration, product category, available studies, anticipated questions from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPLWMiPB), and possible solutions to avoid additional, complex questions that significantly increase costs and extend the registration process.
Preparation of expert reports, overall Quality Overview Summary (QOS), and preparation of Modules 4 and 5 for Well Established Use (WEU) products.
Preparation of responses to procedural questions from URPLWMiPB as well as substantive questions related to documentation, studies, or dossier content.
Coordination of leaflet readability testing (PIL readability testing, PIL user testing) in accordance with current EU and European agency guidelines.
Preparation of registration documentation and substantive evaluation of documentation regarding future registration, product category, available studies, anticipated questions from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPLWMiPB), and possible solutions to avoid additional, complex questions that significantly increase costs and extend the registration process.
Preparation of expert reports, overall Quality Overview Summary (QOS), and preparation of Modules 4 and 5 for Well Established Use (WEU) products.
Preparation of responses to procedural questions from URPLWMiPB as well as substantive questions related to documentation, studies, or dossier content.
Post-authorization variations and notifications
We provide support related to maintenance of marketing authorization, including post-authorization variations, and notifications within all registration procedures.
We support implementation of changes in product information and printed materials.
We support implementation of changes in product information and printed materials.
Renewals
Preparation of the renewal application
Verification of the dossier for possible necessary post-authorization variations before submission
Preparation of annexes and accompanying documentation for the application
Verification of the dossier for possible necessary post-authorization variations before submission
Preparation of annexes and accompanying documentation for the application
Medical Devices and Food Supplements
We offer comprehensive registration services for dietary supplements including:
- Expert assessment of your product’s eligibility as a dietary supplement
- Professional preparation of packaging labelling that meets regulatory standards
- Coordination of scientific opinions, when needed
- Efficient notification to the Chief Sanitary Inspectorate (GIS)
- Registration of medical devices with URPLWMiPB
Documentation audits
We offer comprehensive audits of registration documentation including:
- Comprehensive verification of data accuracy and completeness within the registration dossier
- Preparation of a structured, regulator-ready audit report
- Assessment of the current regulatory status of your product
- Strategic advice on selecting the most appropriate registration pathway
- Risk evaluation tailored to your product’s specific registration context
