- Consultancy
Strategy and procedures
- Services
- Solutions
Dossplorer regulatory dossier viewer
Submission document templates and content plan
- Customers & Cases
Registration tracking
Manage the complex task of medicinal product- and registration tracking, planning and reporting
Registration tracking, planning and reporting on clinical trial authorization applications and marketing authorization applications is a complex task. This is due to the many variables across products and countries.
The variables include descriptions and identifiers of registered products, substances, pharmaceutical products, packaged components and manufactured items to describe the product characteristics. It also includes the context of products such as, by whom is it registered, where, and since when, who approved it, and who manufactured it. In the end, all this information is to be registered to allow for attributing adverse events to the registered product, the pharmaceutical product, a packaged component, a drug substance or a manufacturer. As a result, signal detection can be improved and corrective actions can be made to reduce hospitalization and deaths due to changes in any of those variables.
Lack of authoritative data sources and common terminology
Too often companies have multiple sources with differing terminology for the same information. As a result, employees cannot rely on the information in their Regulatory Information Management (RIM) system completely. The true data is somewhere, obviously, but lack of trust makes people set up their own spreadsheets and databases. So, any time a question is raised, these different sources need to be verified.
Similarly, regulators face the same problems with having multiple sources for the same information and inconsistent terminology. Therefore, the EU regulators implemented a structure called XEVMPD and initiated the development of ISO IDMP. IDMP is a further extension of XEVMPD-like data and data types). Both the EU-EMA and US-FDA are developing standardized terminology to be used for the IDMP structure. The industry should take advantage of these initiatives as they are key to manage unambiguous authoritative data sources within their own organizations. This should be seen as an opportunity for successful digitalization and not only as a compliance-related challenge.
Our services
We help companies to establish a strong and reliable RIM solution. One that can be used as a transparent source of truth across regulatory affairs and beyond. In more detail, this includes efficient registration planning, tracking and reporting and timely management of health authority correspondence and commitments.
Firstly, our specialists know the relationships between the data and what controlled terminology can be used. Secondly, how software tools need to be configured to facilitate the product registration tracking. Thirdly, our specialists have experience with different regulatory tracking systems. This includes (incl. ArisGlobal Register, Samarind RMS, and Lorenz drugTrack). Finally (and most importantly), they have a thorough understanding of the business context.
Qdossier helps to streamline end-to-end regulatory information management by optimizing daily business workflows. Our consultants understand the importance of data governance, minimizing data duplication, real-time availability of data, and flexible reporting. So consequently, this will help you implement the right combination of technical and procedural measures to achieve this and support different regulatory use cases. These use cases extend beyond the Regulatory Affairs department and include Change Control, Safety Reporting, XEVMPD, and Serialization.
Our data stewards support managing your structured product data. This includes data remediation, maintenance, restructuring, and cleansing. For example, the structuring of substance information, packaged medicinal product information, details related to indications and contra-indications, and submission of authorized product information in XEVMPD.
We offer our extensive domain knowledge combined with our passion for digital transformation to build transparent RIM solutions. At the core are seamless processes.
Qdossier helps companies to align people, processes and tools for IDMP. This will not only lead to ISO IDMP compliance, but will drive digital transformation within your Enterprise.
Data and document migration requires knowledge about the context and content of the data and documents. It requires a thorough understanding of the destination, granularity, controlled dictionaries, meanings and business rules.