16 Sep Adapting to Change with Agile Service Models and Customizable Solutions at PharmDedict

Posted at 17:47h in Problem-Solution

In the fast-evolving highly regulated pharmaceutical industry, staying ahead of regulatory changes, technological advancements, and market demands is а critical factor of success. At PharmDedict, we understand that agility and customization are key to meeting the unique needs of our clients. That's why we've adopted...

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26 Aug Effective Regulatory Affairs Consultancy through Collaborative Project Management

Posted at 17:51h in Regulatory Affairs

In the dynamic world of pharmaceuticals, regulatory affairs (RA) play a critical role in ensuring that products meet all necessary legal and safety requirements before reaching the market. However, with the complexity of regulations and the ever-changing global landscape, RA departments are facing increasing challenges....

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19 Jul The Bulgarian digital healthcare experience: Modernisation of the NHIS

Posted at 19:00h in Legislation

On July 5, 2024, significant amendments to Ordinance No. H-6 were promulgated, affecting the Bulgarian National Health Information System (NHIS). These changes aim to improve access to health information and enhance personal data security. What's changing? 1. Mobile Access through "eHealth" The major innovation is the ability to...

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22 May New disposal claim for medicines in Romania

Posted at 13:14h in Regulatory Affairs

On May 20, 2024 the Romanian Drug Agency posted an announcement about the necessity to amend the Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) regarding the waste management of unused and/or expired medicines from the population, as follows: Annex 1 (PIL) to...

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08 Apr Simplify your promotional materials approval process

Posted at 11:44h in Problem-Solution, Regulatory Affairs

Have you ever struggled with the local adaptation and approval/notification of promo materials for medicinal products? If yes, then you know it could be challenging and you might be interested to see our successful experience with promotional materials in Bulgaria. The legal provisions that contain guidelines...

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19 Mar Day Zero in Local Literature Screening

Posted at 10:50h in Pharmacovigilance

The interpretation of day 0 in local literature screening historically encountered challenges, particularly regarding hard copy journals. In January 2023 European Medicines Agency (EMA) posted an interesting view of the Pharmacovigilance Inspectors Working Group regarding Day 0 in the context of Individual Case Safety Reports...

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11 Mar Gergana Semova: bridging science and market

Posted at 13:49h in Company News, Highlights

Vagabond Magazine*: The General Manager of PharmDedict knows the ins and outs of drug regulations Drugs in the pharmacies have gone a long way before reaching us and improving our health. To a significant extent, this is thanks to the work of companies such as PharmDedict....

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11 Mar Why do you need local regulatory intelligence in pharma sector?

Posted at 10:00h in Legislation, Problem-Solution, Regulatory Affairs

Regulatory Intelligence, as a systematic approach, includes the processes of regularly and proactively collecting regulatory information and analysing the latest updates that impact the operations of an organization. Regulatory Intelligence helps companies cope with the dynamics in regulations, accommodate changes, and ensure compliance. On February 23,...

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21 Feb Transfer of Marketing Authorisation: What you should know for Bulgaria?

Posted at 12:34h in Problem-Solution, Regulatory Affairs

A Transfer of Marketing Authorisation (MA) is the formal process for medicinal products through which the MA shifts from the current approved Marketing Authorisation Holder (MAH) to a new MAH, which is a distinct legal entity. This transfer may be prompted by a strategic decision...

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05 Feb How do you ensure RA continuity during a well-deserved break, maternity, or long sick leaves?

Posted at 14:51h in Problem-Solution, Regulatory Affairs

In the fast-paced world and dynamic environment of a Pharma Company where critical business processes demand constant attention, the Regulatory Affairs (RA) Managers often find themselves facing a dilemma, especially in the holidays season, but not only...

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