IT Consulting Life Science
IT-Consulting Lífe Science stands for qualified consulting in the domain of life science. We support you in a wide range of processes and structures of your enterprise – from a short-term task to a major program – for all company sizes, and from A to Z.
[itcls.eu] Website: http://www.itcls.eu
IT-Consulting Life Science was founded by Dr. Dieter Schlaps. At Wessobrunn, a historically well-known town in Upper Bavaria, we have established ourselves as your competent partner for all consulting topics around your pharmaceutical R&D processes.
Our well-established and trustful relationships to the leading German and International Pharmaceutical companies are founded on our customer- and goal-oriented service approach, which is continuously refined in order to match the changing Regulatory and Business environment.
Regular information exchange with our network of clients and partners, our own research and development activities as well as academic engagements at leading universities as well in the ISO standardization activities around IDMP are a solid basis for the successful execution of our consulting projects.
Drug Regulatory Affairs (DRA) are challenged permanently by new regulations: New national or international standards are impacting the processes and IT-systems in the national and headquarters’ DRA departments. The e-CTD Standard is establishing itself as a true global standard with the consequence that an increasing amount of regulatory documentation is now available in the standardized structures of eCTD resp. NeeS. With this, interesting new options for improving the efficacy of submission processes are opening up: E.g. the reuse of dossier parts, the use of “core dossiers” or “dossier templates” becomes a realistic option for efficacy improvements!
The adoption of the IDMP standards by the European and US Health Authorities means a paradigm change in the management of pharmaceutical product information: Beginning 2016 product information will have to be coded according to a large number of controlled vocabularies and submitted to the Health Authorities. With these data becoming available, health authorities will be enabled to compare existing and new products, e.g. within the context of a benefits-risk assessment, with much more precision and much more efficiency than today. As IDMP draws its data from several areas of the pharmaceutical product value chain, the implementation of IDMP may mean a major endeavor for any Pharmaceutical company.
With more than a decade of experience in Regulatory Affairs, we are your reliable partner to support you in all DRA processes.
In a nutshell:
- Analysis of DRA processes (e.g. using Six-Sigma methodology)
- Development of Business Cases and derivation of Strategies
- IDMP-Awareness workshops
- Analysis of the existing DRA IT infrastructure with respect to the possibility to extract data for IDMP submissions and mapping the IDMP data model to existing data structures with Gap-analysis
- Requirements analysis for Regulatory IT solutions (DMS, RIMS, eCTD, Planning, Tracking, etc.)
- Support in the Vendor Selection process
- Substance identification and establishment of an IDMP-ready Substance Database
- Support for implementation projects (Project management, validation, coaching)
- White papers: The Main Challenges around IDMP and how to solve them