Throughout our successful track record as a leading solutions provider for the Life Sciences industry, EXTEDO has successfully partnered with countless SMBs (small and medium sized businesses). Our software solutions and tailored services are designed to meet the needs of companies of any size. In addition to our successful work with SMB organisations, we have a proven track record of collaborating with CROs around the world. As the only vendor on the market able to cover the entire regulatory landscape, we are able to offer CROs & SMBs configurable off-the-shelf solutions designed to meet their business and regulatory needs.
- Registration Management for XEVMP, IDMP and master data management
- Submission Management including publishing, validation, viewing and reviewing
- eCTDmanager National Procedure Package (for eCTD in Europe)
- Document Management
- Planning & Tracking
- Safety Management - Multivigilance for pharma, medical devices, cosmetics and nutrition
BlueReg Pharma Consulting is an independent Regulatory Affairs and Pharmacovigilance service company. They specialize in the writing, preparation and submission of regulatory dossiers. With an ever-increasing client base, BlueReg was faced with the challenge of streamlining its process for compiling and managing regulatory dossiers.
OptumInsight (now ICON) provides global regulatory consulting services for the pharmaceutical, biotechnology and medical device industries. In order to better support their clients they needed to make the switch from paper to electronic submissions. After a detailed selection process OptumInsight deployed EXTEDO’s eCTDmanager as a primary tool for filing regulatory submissions electronically.
In this whitepaper we explore the benefits of Regulatory Information Management Systems as a catalyst for technological and process innovation. We also uncover the way in which they are helping life science organizations, of all sizes, to manage the costs associated with regulatory activities.