How to Contract REACH Testing Labs and Manage Certificates for US Pharma Supply Chains in 2023 How to Contract REACH Testing Labs and Manage Certificates for US Pharma Supply Chains in 2023 The global landscape of regulatory compliance is continually evolving, posing significant challenges for pharmaceutical companies operating in the U.S. market, particularly regarding EU REACH and RoHS compliance. For organizations involved in importing and exporting chemicals, understanding the intricacies of REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) is crucial. This article serves as a step-by-step tutorial guiding entities through the processes of contracting REACH testing laboratories and managing…

REACH Compliance Clauses for Quality Agreements With EU Customers in 2023 REACH Compliance Clauses for Quality Agreements With EU Customers in 2023 As the regulatory landscape continues to evolve, companies managing supply chains in the pharmaceutical industry must ensure compliance with EU REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) regulations. This step-by-step guide will detail the necessary REACH compliance clauses to be included in quality agreements with EU customers. Compliance not only mitigates legal risks but also strengthens supply chain relationships. In this guide, you will find specific actions to take, documentation requirements, and practical checklists to support EU…

REACH Restriction Risk Assessment (Annex XVII): How to Screen Formulations and Materials in 2023 REACH Restriction Risk Assessment (Annex XVII): How to Screen Formulations and Materials in 2023 With increasing regulatory scrutiny on chemical substances in products within the European Union (EU), organizations engaged in the pharmaceutical sector must navigate the complexities of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) compliance framework, particularly pertaining to Annex XVII restrictions. This comprehensive guide provides practical steps for performing a Restriction Risk Assessment under Annex XVII of REACH, focusing on how to screen formulations and materials effectively in 2023. Step 1:…