Blog Post Life Sciences Pharma How to Prepare for ICH E6(R3): The Future of Clinical Trials The International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines received a major facelift in a global effort to ...
Blog Post Life Sciences Quality + Compliance What You Need to Know About FDA Remote Regulatory Assessments The Remote Regulatory Assessment (RRA) was originally introduced in an April 2021 Guidance for Industry as a Remote Interactive Evaluation ...
Case Study Pharma Quality + Compliance Managing PAI and BIMO Inspection Readiness Clarkston recently partnered with a client on a PAI and BIMO inspection readiness project. This client is a biopharmaceutical company ...
Blog Post Food and Beverage Consumer Products The New Era of Smarter Food Safety In April 2019, the FDA released the New Era of Smarter Food Safety initiative, which outlines their approach around food safety over ...
