Assistance for dossier preparation, production, submission and maintenance
Assistance for dossier preparation, production, submission and maintenance
- Preparation and publishing of documents and regulatory documentation throughout the product life cycle on an insourcing, outsourcing or mixed basis
- Assistance and support for choosing, validating, implementing and operating systems for dossier publishing and product documentation management
- Assistance with optimizing/streamlining the company dossier preparation, publishing and
maintenance processes:
- Processes alignment with regulatory requirements
- Processes evaluation, optimization and adaptation for increased operational efficacy
- Medical and scientific writing (CMC, clinical and non-clinical)
- Dossier publishing and submission:
- Compiling and reformatting of electronic documents and CTD Modules
- Scanning of existing paper documents and conversion of the CTD to eCTD Format
- Preparation for eCTD or NEES publishing
- Variations management on an insourcing, outsourcing or mixed basis
- Comprehensive quality control of all documents
- Communication with regulatory authorities.
Latest News
Monday 26.03.2012
Exhibition in Copenhagen: Join us at the 24th DIA Euromeeting
Read more
Monday 30.01.2012
Conférence à Paris: ProductLife participe à l'évènement sur la Cosmétovigilance organisé par la FEBEA
Read more
Tuesday 24.01.2012
Kompaktseminar in Berlin: EVMPD - praktische Umsetzung bis Juli 2012
Read more
