Blog
Importer’s Warehouse – Permits, GMP Requirements, and Key Differences from a Pharmaceutical Wholesaler
14 listopada 2025
Importing medicinal products into the European Union is not merely a matter of logistics and trade. It is, above all, an activity strictly regulated by pharmaceutical law, in which quality, safety, and compliance with Good Manufacturing Practice (GMP) requirements are key. By definition, import also includes storage, quality control during batch release, and distribution. One of the most important elements of this entire process is the […]
Safety data exchange: modern must-have to maintain Pharmacovigilance
27 października 2025
Safety data exchange is a crucial domain in the Pharmacovigilance area, ensuring that all safety information is shared effectively and efficiently. Safety data can be understood as detailed information about a chemical/ biological substance or mixture, including its impact on health, properties, threats, risks, and security measures. Timely safety data exchange is the key to fulfilling the legal obligations imposed on the Marketing Authorization Holder (MAH) by pharmaceutical […]
New era of precision medicine: How genetic tests are revolutionising clinical trials
14 sierpnia 2025
One of the most significant advantages of genetic testing in clinical trials is its ability to identify patients who are most likely to benefit from a given therapy. However, the benefit is not only for patients, but also for the sponsor of the study, as the more precise recruitment increases the chances for desirable test results. By analysing a participant’s DNA, researchers can pinpoint specific genetic mutations […]
Getting a Handle on the Pharma World: Why Market Research and Planning Are Key
16 kwietnia 2025
Getting a Handle on the Pharma World: Why Market Research and Planning Are Key Let’s face it: the pharmaceutical industry is a constantly shifting landscape. If you want to make a real impact and succeed, just having great drugs and following the rules isn’t enough. You’ve got to get the market and have a smart marketing plan in place. When you have solid market insights, […]
World Backup Day – Regulatory Requirements and Best Practices
20 marca 2025
On March 31st, we celebrate World Backup Day. It’s a perfect opportunity to remind you about one of the key issues in data security, particularly in the pharmaceutical industry. With the ongoing digital transformation that enables more effective management of documentation and processes, data protection becomes a crucial element in ensuring regulatory compliance and business continuity. Why does your company need backups? Compliance with regulatory […]
Exploring the potential of Nanoparticles and Nanotechnology systems in medicinal products development and registration
18 lutego 2025
Have any of you used them? Had a contact with them? Nanoparticles are everywhere around us. Undetectable by the human eye, nanoparticles can exhibit significantly different physical and chemical properties to their larger counterparts. Researchers realized the importance of nanoparticles when they found that size can significantly influence the physiochemical properties of such substances. Although, currently, there is a coexistence of different definitions of nanomaterials […]
AI-Enabled Medical Devices – EU’s New Regulatory Landscape
13 stycznia 2025
The Growing Role of AI in Digital Health Artificial Intelligence has evolved significantly since Christopher Strachey developed the first AI program in 1951 (Alowais 2023). In its early stages, AI was mainly a subject of academic study. The field took a major step forward in 1956 when John McCarthy hosted the Dartmouth Conference and introduced the term „Artificial Intelligence”. Today, AI is defined as the […]
What’s the deal with vitamin D?
18 listopada 2024
What is vitamin D? Vitamin D is a series of organic chemical compounds, the most important of which are cholecalciferol (vitamin D3) and ergocalciferol (vitamin D2). They differ chemically only in their side-chain structures, but both play the same role in the body. Both vitamin D3 and D2 are inactive, and only in the body are they transformed into biologically active forms: calcitriol […]
Regulations for psychotropic medications in Poland
09 października 2024
According to Article 41 of Polish Act of 29 July 2005 on Counteracting Drug Addiction, retail trade in psychotropic substances and precursors that are medicinal products shall be conducted by pharmacies, ensuring appropriate storage conditions preventing unauthorised access to these drugs and substances. Additionally, it should be noted that medications containing psychotropic substances shall be dispensed from the pharmacy only on the basis of a specially labelled prescription or requisition […]
Pharmaceutical forms of medicines: from classic to modern solutions
20 września 2024
World Pharmacist Day provides an excellent opportunity to explore the variety of pharmaceutical forms of medicinal products that play a key role in the daily lives of millions of patients around the world. Modern pharmacy is not limited to pills and syrups – it also encompasses modern technologies and innovative solutions that are transforming the landscape of treatment forms. The choice of whether a drug is enclosed in a capsule or administered in liquid […]
Supply chain optimization for medicinal product safety
22 sierpnia 2024
In the summer period, as temperatures rise, ensuring the safety of medicinal products becomes important. High temperatures may significantly affect product quality, leading to serious consequences for patient safety and regulatory compliance. Therefore, the optimization of the cold chain supply is a key element of the strategy for every pharmaceutical company. This article discusses the importance of cold chain management in the pharmaceutical supply chain, […]
Buzzing Mutual Benefits: The vital role of bees in medicine and novel veterinary medicinal products to protect honeybees
25 lipca 2024
August is a month, in which in Poland we celebrate the Great Bees Day. It is a suitable occasion to provoke us to think about how much we owe bees and what the world could look like without them. We can spill the beans and admit that humans cannot survive without these tiny creatures. Fortunately, we have some options to protect them and humans from disaster. Let’s look at what bees […]