Home Who we are Regulations Consulting Staff Publications Contacts Home / Consulting / ERA On 1 June 2006 the European Medicines Agency (EMEA) published the final document on ERA (Environmental Risk Assessment) relating to medicinal products for human use. This document was adopted by the CHMP and entered into force on 1 December of the same year. Each application for marketing authorization for a medicinal product for human use must be accompanied by an ERA. Pursuant to Article 8 (3) of Directive 2001/83 / EC, and subsequent amendments (such as Directive 2003/63 / EC), the assessment of the potential environmental risks deriving from the drug must be presented. The environmental impact should be assessed and, as appropriate, specific provisions should be considered to limit it. The risk assessment is prepared using software: EUSES (European Union System for Substance Evaluation). The document is coded as EMEA / CHMP / SWP / 4447/00. Thanks to its vast technical experience, Chemsafe is able to support pharmaceutical companies in assessing the environmental risk of new drugs. Le offerte di ChemSafe circa le attività correlate alla preparazione dell'ERA sono le seguenti: Corsi di formazione Fase I Analisi della persistenza, del bioaccumulo e della tossicità (valutazione PBT) Calcolo della PEC (Concentrazione Ambientale Predetta) Fase II, livello A Pianificazione dei test (comparto acquatico) Monitoraggio dei test e degli studi Calcolo della PNEC (Concentrazione Non-Efficace Predetta) Analisi degli effetti e valutazione del rischio Fase II, livello B Pianificazione dei test e raccolta dei dati (programma esteso) Monitoraggio dei test e degli studi Analisi degli effetti e valutazione del rischio Contatti e discussioni con le Autorità competenti Stesura della relazione finale e di sommari esaustivi Caratteristiche del servizio: Unica persona di riferimento Approccio flessibile Prezzi competitivi Risposte veloci Pianificazione della fatturazione del progetto adattabile su richiesta Convenienti condizioni di pagamento Visit to customers REACH REACH-like CLP (Classification, Labeling and Packaging) SDS / eSDS Only Representative (OR) Pesticides WAS Cosmetics CTD Nanomaterials Biocides Special Services Consortium management Endocrine disruptors USA Ecolabel QSAR Occupational Exposure Limits (OEL) Legal Service Chemsafe was founded in 2001 and is based in the "Silvano Fumero" Bioindustry Park. The company now employs 12 people divided into 6 operational groups: REACH registration, OR and Consortium / SIEF management, Classification and labeling, biocides and pesticides registration, Business Development and special projects. By registering you authorize the processing of your data Chemsafe srl Via Ribes, 5 10010 Colleretto Giacosa (TO) - Italy VAT number: 08274890014 Telephone: +39 0125 538888 Fax: +39 0125 538475 Email: go to the contact form Copyright © 2015, Chemsafe srl - VAT number: 08274890014 Web Design by ZioSEM - Powred by x-media