The Registration Unit was established in 2002. The medicinal products registration processes are performed for the Pharmaceutical Research Institute as a marketing authorization holder, but also for the co-operating pharmaceutical companies. In the latter case, the documentation in the Common Technical Document (CTD) format is usually prepared as the final step of the drug development.

Registration Unit's main tasks include:

1. Keeping up-to-date with the current medicinal product registration requirements.
2. Close co-operation with the registration authorities in Poland (The Office For Registration Of Medicinal Products, Medical Devices And Biocidal Products; National Medicines Institute).
3. Information and training activities for conducting research and development projects according to the current registration requirements.

Our services include:

1. Preparation of the registration documentation.
2. Evaluation of the registration documentation.
3. Organization of the registration process.
4. Organization of the reregistration process.
5. Introduction and organization of the post-registration changes.
6. Coordination of the information documents and expert reports preparation.

Staff:

• Scientific staff - 3 persons

Contact:	Maria Mazgajska, Ph.D.
Phone:	(+48 22) 456 38 18
Fax:	(+48 22) 456 38 38
E-mail: