Blog
Importing Medicinal Products: GMP Requirements and Customs Clearance Challenges
10 December 2025
Importing medicinal products into the EU is a highly regulated process that leaves no room for error. From strict GMP expectations to complex customs procedures, each step can affect timelines and product quality. This article explores the main regulatory challenges and highlights practical strategies that help importers avoid delays, ensure compliance, and protect product integrity. Key GMP Requirements for […]
Importer’s Warehouse – Permits, GMP Requirements, and Key Differences from a Pharmaceutical Wholesaler
14 November 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 […]
How can an internal Quality Management System support a company that operates in accordance with regulations?
28 October 2025
In today’s rapidly changing pharmaceutical environment, quality is not just a set of procedures – it is the strategic foundation of trust for patients, regulators, and partners. In this article, we will show how an internal Quality Management System (QMS) can become a powerful driver of continuous safety, regulatory compliance, and effective performance in multiple fields, including the consulting area. Core Elements of QMS At the heart of the organization’s QMS […]
Safety data exchange: modern must-have to maintain Pharmacovigilance
27 October 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 August 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 […]
Centralised procedure – the European Union-wide procedure for the authorisation of medicines
30 June 2025
Registration of medicinal products is a key process that ensures that all medicines distributed and sold in the European Union (EU) meet established quality, safety and efficacy standards. Therefore, regulatory systems across the EU have been carefully designed to thoroughly evaluate medicinal products before granting marketing authorisation (MA). Applicants can use several ways to obtain EU MA: the national procedure, the […]
Pharmacological Photosensitivity: Dual Impact of UV Radiation on Skin and Drugs
17 June 2025
As temperature rises and sunny days become more frequent, many people take advantage of the longer daylight hours to spend more time outdoors. Whether it’s a walk in the park, a weekend at the beach, or simply running errands in the sun, it’s important to recognise that certain medications can significantly increase the skin’s sensitivity to ultraviolet (UV) radiation. This often-overlooked side effect, known as drug-induced photosensitivity […]
Getting a Handle on the Pharma World: Why Market Research and Planning Are Key
16 April 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 March 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 February 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 January 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 November 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 […]