Scientists providing logical solutions
Specialist support for pharmaceutical companies
Many years of experience and a team of experts
About us
Pharmalogics advisors provide the pharmaceutical industry with their definitive expertise in the developmental and registration processes 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 startegic decision making, 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 with many ears of experience in medical-regulatory writing for pharma industry. 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. Simple organisational structure allows Pharmalogics to timely provide high quality services tailored to needs of both small entities as well as Big Pharma Clients.
Services
REGULATORY AFFAIRS
- CTD dossiers preparation, updates and addenda for generic, hybrid, well-established use and innovator medicinal products
- Support in drafting and updates of Product Information
- CTD dossier due-diligences prior to submissions, licensing or acquisitions
MEDICAL DEPARTMENTS
- Non-clinical and clinical research scientific support
- PIPs dossiers and SAs briefing books
- Medical Advisor services: sales REPs trainings, Regulatory Affairs and Marketing Departments support, Medical Information
MEDICAL DEVICES MANUFACTURERS
- Scientific Support in Clinical Studies and PMCFs planning
- Support in IFU drafting, verification and updates
- Clinical Evaluation Reports (CERs) preparation and updates
- Biological Evaluation Reports (BERs) preparation and updates
- Scientific literature reviews supporting materiovigilance activities
- Audits of biocompatibility dossier vs ISO 10993 standards series
