The 5 Major Enemies of a Regulatory Dossier
Preparing and submitting a regulatory dossier remains one of the most critical yet vulnerable processes in the pharmaceutical industry. The pressure to meet deadlines, ensure quality, and avoid rejections from regulatory agencies like AEMPS, EMA, or FDA can be overwhelming. Despite technological advancements, many teams still face obstacles that compromise the efficiency and accuracy of […]
Pharmaceutical Registrations: When the Procedure Becomes the Greatest Risk
In the pharmaceutical industry, the preparation and management of registration dossiers continue to be one of the greatest operational challenges for technical and regulatory teams. Despite a high level of regulatory compliance and increasing technical complexity, many processes are still approached using traditional methodologies and limited tools. This turns the procedure into an operational burden […]