APC Instytut is member of www.REGULANET.org - local representation for Global Regulatory Affairs.

APC Instytut is local consultant of the Danish company TARIUS - Global Intelligence of regulatory and compliance regulations for human drugs, biologics and medical devices.

OUR SERVICES:

Carrying out of the full registration process of a medicinal products in the Polish Drug Registration Agency (DRA); obtaining of marketing authorization

Application of medical devices to the Register of Medical Devices

Notification of food supplements and cosmetics in appropriate Polish Agencies

Realization of some parts of the registration process

Prolongation of marketing authorizations

Preparation, translation and adjustment of Patient Information Leaflets, SmPC (Summary of Product Characteristics), mock-ups to the requirements of the Polish DRA

Registration of Clinical Trials in CEBK (Central Evidence of Clinical Trials)

Transfer of marketing authorization

Variations - submission and monitoring

Consultancy in Regulatory Affairs

Consulting on completion of registration dossier

Outsourcing of Regulatory Affairs Specialists

Other