Since 2004, Kateric has been partnering with global biopharmaceutical companies to provide individualized, single source solutions for the preparation of a wide array of regulatory documents. Kateric’s core service areas include: • Regulatory writing and editing of a wide range of products (biopharmaceutical, device, and diagnostics) and document types (e.g., clinical, nonclinical, and safety) across a variety of therapy areas . • Quality control review of regulatory documents • Clinical trials disclosure (CTD) and transparency services including but not limited to management consultation, clinical trial registry authoring (protocol registration and results disclosure) and maintenance, document redaction, plain language summaries, and end-to-end CTD services