Regulatory services, documents and data management
Regulatory services, documents and data management
- Assistance and support for choosing, validating, implementing and operating systems for data and electronic document management, dedicated to R&D and Regulatory Affairs, e.g.:
- Electronic laboratory notebooks
- Tracking and planning of regulatory information/events
- Documents and regulatory affairs databases
- Dossier publishing and product information management systems
- Processes alignment with regulatory requirements
- Processes evaluation, optimization and adaptation for an increased operational efficacy
- Regulatory databases and medical information management
- Regulatory documentation and product information management
- Regulatory operations management by delegation (planning, submissions and post-marketing support)
- Dossier publishing:
- Compiling and reformatting of electronic documents
- Scanning of existing paper documents
- Preparation for eCTD or NEES publishing
- Archiving plans definition
- Existing information, data and documentation scanning and indexing.
Latest News
Monday 26.03.2012
Exhibition in Copenhagen: Join us at the 24th DIA Euromeeting
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Monday 30.01.2012
Conférence à Paris: ProductLife participe à l'évènement sur la Cosmétovigilance organisé par la FEBEA
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Tuesday 24.01.2012
Kompaktseminar in Berlin: EVMPD - praktische Umsetzung bis Juli 2012
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