For every marketing authorization holder (MAH), pharmacovigilance is not just another operational function — it often becomes a constant source of pressure. MAHs are expected to monitor safety, manage risks, and remain inspection-ready at all times, while regulatory expectations continue to grow and evolve. The problem is that most marketing authorization holders quickly find themselves… View Article …
Many companies assume that hiring a RA consultant will immediately bring clarity and control to their regulatory process. On paper, it looks simple: bring in a regulatory affairs consultant, delegate the work, and move forward with confidence. But the reality often looks very different. Regulatory affairs consulting is a highly complex, evolving function that spans… View Article …
EUDAMED European Database on Medical Devices has for years been something companies could postpone. Even as MDR and IVDR reshaped regulatory expectations, many organisations treated it as a future requirement—important, but not urgent. That perception changed fundamentally in November 2025, when the notice confirming the functionality of the first four modules was officially published in… View Article …
Developing and maintaining pharmacovigilance today is no longer just an operational task — it is a constant balancing act between compliance, safety, and control. With increasing regulatory pressure, growing volumes of safety data, and the need for continuous inspection readiness, companies are under more strain than ever to ensure their pharmacovigilance systems actually work as… View Article …
Many companies enter the market with OTC products expecting a faster and simpler regulatory pathway—but quickly run into unexpected complexity. Even a single over-the-counter (OTC) product must meet strict requirements for safety, quality, and correct patient use without medical supervision, which regulators assess very carefully. The problem is that this complexity is often underestimated. Companies… View Article …
When developing class II medical devices, companies often underestimate what they are really stepping into. These devices are typically classified as medium to higher risk, which means stricter regulatory requirements, mandatory involvement of a Notified Body, and a more complex conformity assessment process than for lower-class devices . The problem is that this complexity doesn’t… View Article …
Developing combination products sounds like a strategic advantage—until the reality hits. These products combine drugs, medical devices, and/or biologics into one integrated solution, which immediately multiplies regulatory, technical, and operational complexity, as both pharmaceutical and device requirements must be met simultaneously. Companies quickly realize that what seemed like innovation turns into confusion. Teams struggle to… View Article …
Developing combination products sounds like a strategic advantage—until the reality hits. These products combine drugs, medical devices, and/or biologics into …
Biotech regulatory consulting becomes critical right after closing a Series A round, when most biotech companies expect acceleration — but instead, regulatory complexity starts slowing everything down. What initially looked like a clear path to clinic quickly turns into uncertainty around strategy, data requirements, and interactions with authorities. The problem is that regulatory affairs is… View Article …
Companies rarely search for signal detection service recommendations proactively — they do it when control over safety data starts slipping. What begins as a manageable pharmacovigilance activity quickly turns into a complex, high-pressure process, where growing data volumes, fragmented systems, and limited internal capacity make it difficult to identify what truly matters. The challenge is… View Article …
Bringing a product to market is only the beginning — what follows is often far more complex. Many companies underestimate how demanding post-market surveillance (PMS) can become once real-world data, safety signals, and complaints start accumulating. The problem is that PMS quickly turns into a continuous, resource-intensive process. Internal teams struggle to keep up with… View Article …
Companies searching for alternatives to big pharma RA consultancies are usually facing the same frustrating reality: high costs, slow execution, and a lack of real ownership. Regulatory processes are becoming more complex, requiring not just strategy, but continuous, hands-on support across the entire product lifecycle. Yet many traditional consulting firms still operate in rigid models… View Article …
Za podjetja na področju prehranskih dopolnil nova zakonodaja redko pomeni samo pravno spremembo – pogosto pomeni neposreden vpliv na prodajo, marketing in dostop do trga. Prav to se dogaja z novim zakon o varni hrani in krmi, ki je začel veljati 19. decembra 2025 in že odpira številna vprašanja v praksi. Podjetja se danes soočajo… View Article …
Bringing a medical device to market today is more complex and expensive than ever—especially for small MedTech companies facing rising regulatory costs, unpredictable timelines, and limited internal resources . Without the right support, these challenges quickly lead to delays, budget overruns, and lost market opportunities. That’s why partnering with the right medical device regulatory consulting… View Article …
Preparing a PSUR (Periodic Safety Update Report) does not have to be difficult — yet for many pharmaceutical companies, it is. Teams must analyze global safety data, track regulatory timelines, and compile complex reports while ensuring full compliance with pharmacovigilance requirements. A single mistake or delay in a periodic safety update report can lead to… View Article …
Many medical device companies realize that achieving ISO 13485 implementation is far more complex than simply preparing documentation for certification. Building a compliant quality management system requires deep regulatory knowledge, structured processes, and a clear understanding of how quality, risk management, and regulatory requirements interact throughout the product lifecycle. Choosing the right partner can significantly… View Article …
Many medical device companies realize that achieving ISO 13485 implementation is far more complex than simply preparing documentation for certification. …
For many MedTech and digital health teams, bringing software as a medical device to the European market feels less like innovation and more like navigating an increasingly complex regulatory maze. In the EU, software with a medical purpose must comply with stringent requirements under the Medical Device Regulation (MDR), covering conformity assessment, clinical evidence and… View Article …
The European Commission’s amendment to Implementing Regulation (EU) No 520/2012 — now reflected in Regulation (EU) 2025/1466 — marks a significant evolution in how pharmacovigilance must be structured, controlled, audited, and documented across the EU. Marketing authorisation holders (MAHs) now face clear, enforceable expectations about how their safety systems operate, the oversight of external providers,… View Article …
The European Medicines Agency (EMA) has clarified regulatory expectations for signal management with updated guidance following the revised Implementing Regulation (EU) 2025/1466 and an EMA Q&A document published in January 2026. These changes mark the end of the EudraVigilance signal detection pilot and establish a mandatory requirement for Marketing Authorisation Holders (MAHs) to systematically integrate… View Article …
The European Medicines Agency (EMA) has clarified regulatory expectations for signal management with updated guidance following the revised Implementing Regulation …
