Submission Services

Ensuring timely and compliant submissions for regulatory agencies worldwide

Submission Services

Ensuring timely and compliant submissions for regulatory agencies worldwide

Pharma IT can provide expert assistance in regulatory submission

We can help you prepare and submit compliant and timely submissions to regulatory authorities. Our consultants have extensive knowledge of and experience working within regulatory submission guidelines across regulatory environments.

We possess the technical know-how necessary to assist you with eSubmission Compilation

Our publishing team can assist you with your electronic (eCTD, NeeS) submission tasks and ensure eSubmission documentation has all of the required settings to be accepted by the relevant health authority. We can work within your publishing solution or provide submissions services based on our own validated platform, including providing templates tailored to your needs.

Our team helps you ensure Document Submission Readiness

By addressing document readiness as early as possible and ensuring your documentation is created correctly from the start, our team can improve the efficiency of your submission processes.

Suzette Reenmers, Principal

Pharma IT can deliver complete,
end-to-end assistance with submission

“We can help to ensure your documentation is submission-ready, and even work with you to establish consistent standards and instructions that are reflective of eCTD specifications from the start. Early document submission readiness can lower the overall project time and produce significant savings in delivering the dossier to health authorities.”

Suzette Reenmers
Principal

Pharma IT can provide expert assistance in regulatory submission

We can help you prepare and submit compliant and timely submissions to regulatory authorities. Our consultants have extensive knowledge of and experience working within regulatory submission guidelines across regulatory environments.

We possess the technical know-how necessary to assist you with eSubmission Compilation

Our publishing team can assist you with your electronic (eCTD, NeeS) submission tasks and ensure eSubmission documentation has all of the required settings to be accepted by the relevant health authority. We can work within your publishing solution or provide submissions services based on our own validated platform, including providing templates tailored to your needs.

Our team helps you ensure Document Submission Readiness

By addressing document readiness as early as possible and ensuring your documentation is created correctly from the start, our team can improve the efficiency of your submission processes.

Pharma IT can deliver complete, end-to-end assistance with submission

“We can help to ensure your documentation is submission-ready, and even work with you to establish consistent standards and instructions that are reflective of eCTD specifications from the start. Early document submission readiness can lower the overall project time and produce significant savings in delivering the dossier to health authorities.”

Suzette Reenmers
Principal


Regulatory Submission Services List

  • eSubmission compilation on customer or Pharma IT platform
  • Document Submission Readiness Review
  • Assistance creating templates and standards for Submission ready documents
    • Report compilation (e.g, RMP, PSUR)
    • eCTD system implementation, support & maintenance, operational consultancy
    • eSubmission Strategy (Core/country dossiers etc.)
    • eCTD Training

    Do you need submission support?

    Pharma IT can provide end-to-end submission assistance

    Do you need submission support?

    Pharma IT can provide
    end-to-end submission assistance