Registration of medicinal and life science products

APC Instytut is a member of the EuDRAcon organization – an international network of companies involved in the Regulatory Affairs.

OUR SERVICES:

  1. Carrying out of the full registration process of medicinal products in the Polish Drug Registration Agency (URPL); obtaining of marketing authorization.
  2. Preparation, translation and adjustment of Patient Information Leaflets (PIL), SmPC (Summary of Product Characteristics), mock-ups to the requirements of URPL (including Braille).
  3. Variations – submission and monitoring.
  4. Renewals of marketing authorizations.
  5. Transfer of marketing authorizations.
  6. Reimbursement issues.
  7. Parallel Import Applications.
  8. e-Submission Management including reformatting from CTD to eCTD or NeeS.
  9. User Testing (Readability Testing) of PIL; preparation, testing, translation and report submission.
  10. Application of medical devices to the Register of Medical Devices.
  11. Notification of food supplements and cosmetics in appropriate Polish Authorities.
  12. Local Pharmacovigilance services.
  13. Registration of Clinical Trials in CEBK (Central Evidence of Clinical Trials).
  14. Consultancy in Regulatory Affairs.
  15. Expert reports.
  16. Documentation audit.
  17. Notification and consulting regarding dietary supplements and medical devices.
  18. Regulatory Affairs Training.
  19. Other.

 

APC Instytut is a Polish consultant for the Danish TARIUS company – which manages an international database of legal acts pertaining to medicines, biological products and medical devices.

Since 2006 the Institute of APC as a partner of LORENZ in Poland, in December 2009, the URPL purchased the “docuBridge” software of Lorenz company, which used to review and evaluate electronic records and thus since 01 January 2010 the Office started applications in the form of eCTD.

The APC Institute is also a member of the international Heap Research network offering services in the field of pharma-economics and of strategic planning for the introduction of medicinal products to the world markets.

The APC Institute is a long-standing member of the Polish Pharmaceutical Chamber of Commerce, and Ms. Agnieszka Buksowicz, director of the department, is a member of the Chamber since April 2013.

YOU ARE KINDLY INVITED

Agnieszka Buksowicz
Regulatory Affairs Director
e-mail: ab(at)apcinstytut.pl