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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...

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...

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,...

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...

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...

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

08 Apr Simplify your promotional materials approval process

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

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

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

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