O nas
Pharmalogics advisors provide the pharmaceutical industry with their definitive expertise
in the developmental processes and throughout medicinal products and medical devices life cycle.
Our scientific aims are to design optimal strategies in every medical or regulatory process that your company may need.
Our experts support registration and variation submissions for medicinal products and medical devices certification, bearing in mind the need of regulatory risk minimisation.
Our employees are exclusively the experts with PhD degrees. Established external experts network, ready to scientifically support the most challenging and demanding projects, consists of the best Polish specialists in their fields
The high quality of dossiers, arguments and discussions being delivered by Pharmalogics’ Advisors is evidenced by continuous cooperation with EU-based Pharmaceutical Companies as well as Big Pharma Corporations. Pharmalogics Company considerably contributed to numerous successful registrations of medicinal products within the EU as well as in medical devices CE marking.
Services
Regulatory Affairs
CTD dossiers preparation, updates
and addenda for generic, hybrid,
well-established use and innovator medicinal products
CTD dossier due-diligences prior
to submissions, licensing or acquisitions
Medical Affairs support
Non-clinical and clinical research scientific support
(e.g. study assumptions and protocol synopsis preparation)
Research protocols
reviews and assessment
Medical Devices
Clinical Evaluation Reports
Biological Evaluation Reports
Audits of biocompatibility dossier
vs ISO 10993 standards series