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Latest 20 Posts

  • Bulgaria and the CESP system
  • BDA: further measures related to COVID-19
  • Bulgaria: State of Emergency
  • Romania: the drug agency announced restrictions related to COVID-19
  • The Pharma Legal Handbook: Bulgaria
  • Changes at the Romanian Drug Agency
  • Bulgaria is included in the GMP Mutual Recognition Agreement between EU and USA
  • Brexit: the exemption for quality control testing
  • Bulgaria: managing alerts during verification and decommissioning of medicines
  • How to use the defective product report to notify a quality defect to the Romanian Drug Agency
  • Bulgarian Drug Agency: reduced timelines for manufacturing authorisations and wholesale distribution licenses
  • Bulgaria changes the structure of its ethics committees in clinical trials
  • BDA: new requirements for the “proof of payment” document
  • The Bulgarian Drug Agency initiates PIC/S membership procedure
  • BDA: Guidance on the implementation of safety features in Bulgaria
  • 10 Years Anniversary
  • PharmDedict on Pharma Boardroom
  • EudraVigilance Go-Live: expecting 22 November 2017
  • The first MRP with RMS Bulgaria is now on track
  • Single central submission now mandatory for all periodic safety update reports.

Networking

We are proud to have been part of the international network of approved consultants working with the former IP & Science business of Thomson Reuters, now Clarivate Analytics.

We are a member of EuDRAcon: the pan-European network of regulatory affairs consultancy companies dealing with medicinal products, medical devices, cosmetics and food supplements.

Contact us

Address: 54 Andrey Lyapchev blvd., floor 2, 1799 Sofia, Bulgaria

Phone: +359 2862 9127

Fax: +359 2862 4652

Email: office@pharmdedict.com

Business Hours:
Monday-Friday: 9:00-18:00 EET

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