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
Category: Business services -> Consulting
APC Instytut Sp. z o. o. |
|||||||
| Street: | Grójecka 22/24/4 | ||||||
| City: | Warszawa | ||||||
| Postal code: | 02-301 | ||||||
| Region: | Mazovia | ||||||
| Country: | Poland | ||||||
| Phone: | +48 22 6686823 | ||||||
| Fax: | +48 22 6689981 | ||||||
|
|||||||
|
|
|||||||
Contact person |
|||||||
| Name and Surname: | Grzegorz Pilecki | ||||||
| Phone: | +48 22 7577939 | ||||||
| Mobile: | +48 501192156 | ||||||