APC Instytut Sp. z o.o. Al. Jerozolimskie 146 C 02-305 Warszawa POLAND
+48 22 668 68 23
apc@apcinstytut.pl

Regulatory Affairs Poland

APC Instytut supports pharmaceutical companies and provides Regulatory Affairs services in Poland since 1996. 

We are a member of the international association of consulting companies in the sector - EuDRAcon (local representation in EU Regulatory Affairs) and are able to offer RA services to our Clients within the European Union.

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

Since 2006 APC Instytut has a co-operation agreement with Lorenz, provider of the eCTD submission software "DocuBridge". "DocuBridge" was purchased by the Polish Drug Agency (URPL) in December 2009 and the Agency is ready to receive and review eCTD and NeeS documentation as from 01.01.2010.

OUR SERVICES:

  • Carrying out of the full registration process of medicinal products in the Polish Drug Registration Agency (URPL); obtaining of marketing authorization
  • Preparation, translation and adjustment of Patient Information Leaflets (PIL), SmPC (Summary of Product Characteristics), mock-ups to the requirements of URPL (including Braille)
  • Variations - submission and monitoring
  • Renewals of marketing authorizations
  • Transfer of marketing authorizations
  • Reimbursement issues
  • Parallel Import Applications
  • e-Submission Management including reformatting from CTD to eCTD or NeeS
  • User Testing (Readability Testing) of PIL; preparation, testing, translation and report submission
  • Application of medical devices to the Register of Medical Devices
  • Notification of food supplements and cosmetics in appropriate Polish Authorities
  • Local Pharmacovigilance services
  • Registration of Clinical Trials in CEBK (Central Evidence of Clinical Trials)
  • Consultancy in Regulatory Affairs
  • Other

CLINICAL TRIALS:

In order to ensure complex services to the pharmaceutical industry, APC Instytut has started since September 2006 co-operation with Lambda Therapeutic Research, a CRO conducting clinical research phase I-III, bioavailability and bioequivalence for registration purposes.

 

 

CONTACT:

Mrs. Agnieszka Buksowicz
Regulatory Affairs Director
e-mail: ab[at]apcinstytut.pl
tel. +48 501 192 143; +48 22 757 79 39; +48 22 668 68 23
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