eSubmission Services
We deliver a compliant submission
Our team of highly skilled professionals has the expertise and practical experience in producing dossiers to satisfy the current formatting requirements of all health agencies: eCTD, paper or NeeS. Whether you are planning to submit a BLA, MAA or other submission our experts can help.
We provide full eSubmission outsourcing services, transforming your documentation to eSubmission-ready documents, compiling your submission according to the latest e-regulations and delivering anywhere in the world. We manage your submission life-cycle, assuring the tightest security and absolute confidentiality throughout, while you focus on your core strengths and capabilities.
Proven processes and the quality of Comply Services’ specialist team can be demonstrated through our record of uncomplicated approval by the regulatory authorities.
We can assist you at all stages of your application:
- project management
- liaison with all regulatory authorities
- proven methodology for planning and communication
- document identification and tracking
- document transformation services
- full quality control on all transformed documents
- comprehensive publishing services
- full quality check on all submission dossiers
- printing and scanning services
- secure storage and shipping directly to all regulatory agencies
- validated eCTD systems and processes
- dossier lifecycle management
Being involved from the beginning, we can help speed up your application procedure and reduce the time to submission e.g. by facilitating document tracking, by using state-of-the-art technology, by applying proven procedures and tools, by performing exemplary quality control.
Have a look at projects done by Comply Services.
We offer access to industry’s best practice
Comply Services offers access to eDocument Management and Tracking systems through a hosted service. Fully compliant systems and processes, for the compliant creation and management of documents and dossiers, enable your company to access industry best practice and avoid high investment costs. The service ensures absolute security of your intellectual property combined with fully tracking capability.