Services for e-submissions include:
- Assisting clients to develop a strategy for transition to electronic submissions
- Helping expand existing experience to different procedures
- Centralised, Decentralised, Mutual Recognition and National Procedures
- Outside EU
- Transition preparation to the next major version of the eCTD (HL7 RPS)
- Assessments of document creation and document management environments and associated processes
- Streamlining of business processes
- Support for development of vendor tools and services
The experience that Marr Consultancy brings to these services includes:
- Long and intimate involvement in the development of eCTD and NeeS specifications
- Key role in the development of various industry best practice and Q&A documents including the MRP/DCP best practice for eCTD and the Centralised Procedure Q&As
- Steering a major pharmaceutical company through transition from paper to electronic production and submissions
- Implementation of document management and template/guidance strategies