The Product Information File, commonly referred to as the PIF, is one of the cornerstone documents required to demonstrate the safety and regulatory compliance of cosmetic products in the European Union. Under the provisions of the Regulation (EC) No 1223/2009, every cosmetic product placed on the market must be supported by a complete and up […]
04
Oct
Oct
Safety Data Sheets, commonly referred to as SDSs, are essential regulatory documents for communicating information on chemical hazards, safe handling, exposure controls and emergency measures. An accurate and up to date SDS supports regulatory compliance, occupational safety and effective chemical risk management throughout the supply chain. The regulatory requirements governing Safety Data Sheets vary across […]
02
Oct
Oct
Genotoxicity assessment for drug and device combination products, covering ISO 10993, extractables and leachables, patient exposure and expert QSAR review.
10
Jul
Jul
The FDA officially recognized EN ISO 10993-1:2025 – “Biological evaluation of medical devices – Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process” on Monday, May 25, 2026. However, the Agency granted only a partial recognition! The 6th edition of ISO 10993-1 has been reshaped with a stronger […]
12
May
May
The control and qualification of impurities remain among the most critical aspects in the development and lifecycle management of pharmaceutical products. However, the recently published reflection paper from the European Medicines Agency signals an important evolution in how non-genotoxic impurities should be assessed, justified, and managed during pharmaceutical development. Until recently, qualification of non-genotoxic impurities […]
15
Apr
Apr
The 6th version of ISO 10993 – Biological evaluation of medical devices — Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process has been released! With the entry into force of Medical Devices Regulation (EU) 2017/745 (MDR), the approach to safety has become even more stringent, especially […]
09
Aug
Aug
The newly released draft of the ICH Q3E guideline represents a significant milestone in the harmonisation of global expectations for the assessment and control of extractables and leachables (E&L) in pharmaceutical products. Building on the foundations laid by ICH Q3A, Q3B, Q3C, Q3D, and M7, it distinguishes itself by adopting a more integrated and systematic […]
05
Aug
Aug
Glyphosate has been undes scrutiny since many years. Discovered in 1970 by a scientist at Monsanto, and since commercialization in 1974, its use has grown to dominate the herbicide market. Over the years, several epidemilogical studies were published, linking the chemical to adverse human health outcomes. Nine epidemiological studies were centered on neurodegenerative outcomes (two […]
18
Jun
Jun
The Environmental Risk Assessment (ERA) play a key role in regulatory submissions for medicines in the European Union. The European Medicines Agency (EMA) requires a clear, evidence-based process to assess the potential environmental impact of active pharmaceutical ingredients (APIs) that enter the environment through patient use. With the updated EMA guideline (EMEA/CHMP/SWP/4447/00 Rev. 1 – EMA […]
Publications
A proposal for the development of a feed consumption database using a standardised feed classification system
25
Sep
Sep
We are excited to finally reveal a project we’ve been working on for the past few years in collaboration with the European Food Safety Authority (EFSA) and Università degli Studi di Milano. ➡ The project was aimed at developing a proposal for the development of a feed consumption database using a standardised feed classification system. […]