To adapt the business process and tools to comply with Regulatory Submission regulation updates and to increase document preparation and management efficiency.
Complete outsourcing of the overall administrative management and accounting processes for a national coordination service newly created in the perspective to manage multiple contracts and related obligations.
Preparation of an important number of variations dossiers in an in-sourcing configuration on the Customer site.
Introducing eCTD format helped the global document management evolution.
How to define and launch a global EDMS, starting from the R&Dís EDMS.
Having to cope with the increasing size of their archives and the obligation of long-term storage of certain sensitive documents, pharmaceutical companies are becoming interested in the electronic archiving of documents and the storage of their paper documents under the best possible conditions..
Opportunity to implement electronic Laboratory notebooks.
Achieving compliance with the European Pediatric Regulation requires the compilation of the pediatric effects described in the marketing authorizations for all the medicines. The highly demanding timetable has forced certain laboratories to create a veritable task force.
The marketing of medicinal products in over 100 countries involves a rigorous und updated follow-up of the global Regulatory Affairs activity.
How an integrated resource management and project management system allows better allocation of resources and activities within the R&D Department.
Quality Doubts Mean EMA to Revisit XEVMPD, Putting Responsibility Back on Industry
Regulatory Information Management Survey of 37 Companies Finds Call for Innovation and Solution Modernisation
9 December Dutch Life Science Conference in Oss, The Netherlands