The quality of any drug and benefit-risk ratio of these drugs for the patient is laid down in regulatory dossiers. Regulatory dossiers are specific to drug and specific to a country, though the under-laying document contents can often be reused across various products, regions and formats. The contents of regulatory dossiers have cost millions, if not billions, though the subsequent retrievability of this information is often limited.
Our mission is to enable users to achieve optimum reusability and consistency in document management across regulatory dossiers by creating transparency. This requires both technical and regulatory knowledge. The Dossplorer viewer has been designed and tested by Regulatory Affairs & Operations professionals with many years of practical experience in the pharmaceutical industry. We approach viewing matters from both a scientific and technical standpoint. Our solution addresses the variety of responsibilities and needs of the various disciplines within pharmaceutical companies and affiliates.
Our team exists of Regulatory Affairs & Operations professionals with many years of practical experience in the pharmaceutical industry. We approach viewing matters from a business perspective whilst liaising with IT professionals.
Director and senior Regulatory Affairs Consultant
Product manager and Regulatory Information Scientist
IT liaison & Program coordinaton