Our dedicated Regulatory Operations team can provide services to support all activities including document formatting, applying full navigational aids, compilation of eCTD applications, technical validation and submission of applications globally.
Each team member works seamlessly with our Regulatory Consultants on regulatory strategies, submission planning and tracking to ensure applications are delivered to a high standard meeting all eCTD compliance requirements and according to schedule.
To support initial marketing applications, we can offer clients access to our Veeva EDMS system which offers collaborative authoring, approval of documents and a reviewing platform to facilitate the authoring and reviewing process. This is a secure environment with a built-in robust security system.
As part of our document management services, we support the preparation of controlled documents including Standard Operating Procedure (SOPs), Work Instructions and Guidance documents.