Consultancy and solutions provider of risk management and compliance services to Life Sciences Industry
Consultancy and solutions provider of risk management and compliance services to Life Sciences Industry
In 2026, the European Food Safety Authority (EFSA) is initiating a significant update of its scientific framework for the assessment of botanicals. A key development is the planned revision of …
Agencija za lekove i medicinska sredstva Srbije (ALIMS) je 02.04.2026. godine objavila obaveštenje o unapređenju postupka izdavanja stručnih mišljenja iz oblasti medicinskih sredstava. U cilju efikasnijeg i standardizovanog procesa, izmenjen …
Medical device companies in the EU should take a note:the updated MIR (Manufacturer Incident Report) form version 7.3.1, published on 23 March 2026, becomes mandatory from 1 May 2026. This …
Recent updates to EU cosmetics legislation further tighten the connection between chemical hazard classification and the use of substances in cosmetic products. The changes significantly expand restrictions on CMR (carcinogenic, …
Ethanol is currently supported for approval as an active substance under the Biocidal Products Regulation (EU) No 528/2012, with use across several key product types. Intended applications If approved, ethanol …
Ako vaše poslovanje uključuje proizvodnju, uvoz, distribuciju ili korišćenje hemikalija – postoji velika šansa da imate zakonsku obavezu angažovanja savetnika za hemikalije. Međutim, čak i kada to nije obavezno, ova …
As of 1 January 2026, an important update to the Regulation (EU) 2017/745 (MDR) reinforces how manufacturers must assess hazardous substances in medical devices—especially phthalates, CMR, and endocrine-disrupting substances.This is …
In updated guidance issued in May 2025, the European Medicines Agency (EMA) has clarified how third-party GMP audits of active pharmaceutical ingredient (API) manufacturers may be used in support of …