Achieve efficiency by using latest development and e-tools
We have been at the forefront of electronic submission of regulatory data since the introduction of eCTD.
We promote advanced use of e-tools for greater productivity in the preparation and submission of eCTD using Agencies’ gateways and portals while being in direct contact with the authorities.
- Comprehensive eCTD services
- eCTD compilation and publishing
- Full life-cycle support for Europe, USA, Canada, Switzerland, Saudi Arabia, GCC, and more
- Information Management (RIM solutions)
- xEVMPD and ISO IDMP experts
- Software installation, training, validation and support
We are up to date with upcoming mandatory format and we can recommend according to timelines. Please be aware that starting in January 2019 all submissions in EEA will have to be sent in eCTD format. Any help you might need with the preparation of baselines, understanding the world of eCTD or choosing the right software, Asphalion would be more than happy to support you and make your eCTD journey both valuable and pleasant.
Regulatory Information Management (RIM)
We are a reference in Spain for all the RIM systems implementation steps ranging from impact assessment, through to managing vendor and solution selection process, and system implementation. Our wide range of RIM services:
- Impact assessment (identification of source fields, systems and gap analysis);
- Project setup and scoping (requirements specification, implementation planning);
- Vendor(s) and solution(s) assessment and selection;
- Project Management for the implementation of complex solutions;
- Full data migration (data clean up, sorting, conversion to standard terms, final migration);
- End-user trainings;
- Validation(s) (preparation and performance of scripts);
- Business consulting and preparation of business processes (SOPs, work instructions, user manuals).
Do you need support or more information about the services? Contact us!