Regulatory Affairs Services in Spain help companies meet national and EU requirements. They manage product registration, technical files, labeling, submissions to authorities, and compliance checks. They guide you through approvals,...... Read More
Author: DDRegpharma
Process validation is set to shift again by 2026 as agencies push for clearer proof that manufacturing systems stay reliable through the full product life cycle. Guidance from the FDA...... Read More
VITALIC® is a technology-driven solution designed to address challenges routinely grappled with by regulatory teams. It offers a single platform that supports regulatory operations, project management, document handling, and global...... Read More
DDReg offers comprehensive regulatory affairs services in the USA, including product classification, FDA submission preparation, cGMP compliance, and expert support for product approval under FDA regulations. As an experienced FDA...... Read More
When a patient’s health seriously deteriorates during a clinical trial due to a medication or any other factor, it must be reported immediately. These are called Serious Adverse Events (SAEs)....... Read More
A gap assessment acts as a diagnostic before the submission starts. It reveals discrepancies between what your dossier (or your design history file, software validation, clinical evidence, etc.) currently holds...... Read More