31 Oct Investing in Excellence: Comprehensive Training on EU Registration Procedures and eCTD Submissions at PharmDedict

Posted at 19:47h in Regulatory Affairs

At PharmDedict, we firmly believe in nurturing our team's talents to achieve excellence. We understand that our people are critical to our success, and that's why we're committed to finding, engaging, and growing the best talent. With a strong focus on local expertise, we recognize...

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02 Jul The Bulgarian Drug Agency officially joined the PIC/S

Posted at 09:41h in GMP/GDP, Regulatory Affairs

The Bulgarian Drug Agency (BDA) officially joined the PIC/S - Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme as its 55th Participating Authority, effective from July 1, 2023. PIC/S is a non-binding co-operative arrangement between Regulatory Authorities in the field of Good Manufacturing Practice (GMP) of...

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09 May Our new location

Posted at 09:50h in Company News

We are pleased to announce that, in order to facilitate the growth of our team, we have relocated our business to a new location. With easy access from the airport and a nearby Metro station, as well as a much larger parking lot available to...

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13 Jan 15 Years In Business

Posted at 11:26h in Company News

We celebrated our 15th anniversary at the end of 2022! We started the company with the idea to tailor our services to the needs of the different types of companies we serve while taking into consideration the particularities of the local markets we operate in....

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17 Mar Digital Health and DHI Cluster

Posted at 11:21h in Company News, Highlights

We are glad to announce that PharmDedict is now part of the family of the Digital Health and Innovations Cluster Bulgaria. The DHI Cluster is a non-profit organization that supports companies and organizations in the field of digital solutions and innovations in healthcare to build...

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28 Sep We have updated our website, come on in and look around!

Posted at 20:06h in Company News

If you explore our website, you may notice some changes. This is because we refreshed the design and made a few enhancements. We hope you like it. ...

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28 Sep Networking: our approach to pan-European coverage

Posted at 19:16h in Company News

In order to achieve the most effective resolution of all regulatory matters, we have chosen to conduct business in a network of selected nationally based companies in almost all of the member states of the European Union plus Norway, Switzerland and Lichtenstein. We are proud to...

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23 Aug The Pharma Legal Handbook: Bulgaria

Posted at 19:05h in Company News

PharmDedict together with the law firm Kinstellar contributed to the first edition of the Bulgarian country report of the Pharma Legal Handbook, which answers essential questions about the legal and regulatory environment for pharmaceuticals in Bulgaria. Our authors provide answers in the fields of manufacturing,...

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14 Aug Changes at the Romanian Drug Agency

Posted at 19:01h in Legislation, Regulatory Affairs

In July 2019, the National Agency for Medicines and Medical Devices (NAMMD) was reorganised and changed its name to National Agency for Medicines and Medical Devices of Romania (NAMMDR). This change needs to be considered in relation to the communication with the Agency and, more...

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23 May Bulgaria is included in the GMP Mutual Recognition Agreement between EU and USA

Posted at 19:00h in GMP/GDP

In May 2019 the Bulgarian Drug Agency (BDA) announced that after auditing the US FDA confirmed the BDA capacity and ability to perform GMP inspections equivalent to the US standards. On the basis of the sector agreement between the European Commission and the USA, there...

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