eCTD (electronic Common Technical Document) Publishing – is now the standard format required for presentation and submission of dossiers to the TGA for support of Prescription Medicine applications. This requires the use of special publishing software and skills and knowledge in the compilation of dossiers using this software. eCTD submissions have become mandatory for all submissions for prescription medicine and high-risk medicines from 1 May 2023. This means that sponsors need to consider preparing and submitting baselines for all of their previously submitted dossiers.

Regulatory Concepts has been submitting dossiers in eCTD  format since 2019. We now have considerable expertise in the electronic submission of many different types of applications including new registrations, variations, notifications and baselines .

Whenever we receive a new product dossier for registration, we recommend that we undertake a Quality Review or GAP analysis of the dossier.

In addition to prescription medicine applications, we utilise the eCTD structure and publishing software for submission of OTC registrations, New Substance applications for Complementary Medicines as well as submissions to New Zealand.

The final published eCTD submission is compatible with all other eCTD publications as a standard format.

From 1 May 2023, the eCTD format is mandatory for all submissions for prescription medicine and high-risk medicines.  This means that where a previous submission has not been done in eCTD format, the sponsor will need to prepare a BASELINE submission. A baseline submission is essentially a compilation of the original dossier for registration, combined with all variations submitted up to the submission of the first eCTD submission made by the sponsor. This is a major task, and requires not just knowledge of the publishing software but an intimate knowledge of submissions and how they are put together.

Regulatory Concepts combines their regulatory expertise with their expertise in eCTD publishing to provide you with hands on assistance and advice in the preparation of your Baseline submission.  With our regulatory expertise we can assess the best way for parts of the dossier to be presented so that future submissions can easily be added into your eCTD structure.

If you are considering putting together a baseline or looking for support for your baseline submission, ask us for a Quality Review of your proposed submission or ask us to assess and provide a quote for the preparation of your baselines.

If you have prepared you submission in eCTD structure but do not have access to the publishing software or have the time/expertise to prepare the final eCTD published dossier – Regulatory Concepts can assist you. Our team can do a Quality review or GAP Analysis on your proposed submission and advise any updates that might be required in order to complete a final eCTD publishing or we can provide suggestions on how to arrange parts of the dossier to ensure that the future eCTD submission can easily fit into the structure of your existing eCTD dossier.

We can prepare your  final  eCTD dossier with  Lorenz validation reports and submit these to the TGA on your behalf.

With our regulatory expertise, we can take this time-consuming task off the hands of your normal regulatory staff so they can continue with the important day to regulatory activities while we help bring your backlog up to date.

A Quality Review or Gap Analysis of a dossier can be a valuable and economical way to determine the likely success of a submission and can forewarn you of any issues that may be raised by the TGA during a product registration.

With eCTD format now being mandatory from 1 May 2023 for all prescription medicine applications, sponsors will need to consider preparing and submitting BASELINES.  A Quality Review of your proposed Baseline by regulatory experts can provide you with important and valuable guidance in terms of streamlining the structure of your dossier so that future submissions can easily be added into your eCTD structure. We can help iron out any validation errors and warnings that may come up as part of the Lorenz validations.

Creating Baselines

From 1 May 2023, the eCTD format is mandatory for all submissions for prescription medicine and high-risk medicines.  This means that where a previous submission has not been done in eCTD format, the sponsor will need to prepare a BASELINE submission. A baseline submission is essentially a compilation of the original dossier for registration, combined with all variations submitted up to the submission of the first eCTD submission made by the sponsor. This is a major task, and requires not just knowledge of the publishing software but an intimate knowledge of submissions and how they are put together.

Regulatory Concepts combines their regulatory expertise with their expertise in eCTD publishing to provide you with hands on assistance and advice in the preparation of your Baseline submission.  With our regulatory expertise we can assess the best way for parts of the dossier to be presented so that future submissions can easily be added into your eCTD structure.

If you are considering putting together a baseline or looking for support for your baseline submission, ask us for a Quality Review of your proposed submission or ask us to assess and provide a quote for the preparation of your baselines.

Finalising eCTD

If you have prepared you submission in eCTD structure but do not have access to the publishing software or have the time/expertise to prepare the final eCTD published dossier – Regulatory Concepts can assist you. Our team can do a Quality review or GAP Analysis on your proposed submission and advise any updates that might be required in order to complete a final eCTD publishing or we can provide suggestions on how to arrange parts of the dossier to ensure that the future eCTD submission can easily fit into the structure of your existing eCTD dossier.

We can prepare your  final  eCTD dossier with  Lorenz validation reports and submit these to the TGA on your behalf.

With our regulatory expertise, we can take this time-consuming task off the hands of your normal regulatory staff so they can continue with the important day to regulatory activities while we help bring your backlog up to date.

Quality Review/Gap Analysis

A Quality Review or Gap Analysis of a dossier can be a valuable and economical way to determine the likely success of a submission and can forewarn you of any issues that may be raised by the TGA during a product registration.

With eCTD format now being mandatory from 1 May 2023 for all prescription medicine applications, sponsors will need to consider preparing and submitting BASELINES.  A Quality Review of your proposed Baseline by regulatory experts can provide you with important and valuable guidance in terms of streamlining the structure of your dossier so that future submissions can easily be added into your eCTD structure. We can help iron out any validation errors and warnings that may come up as part of the Lorenz validations.

Regulatory Concepts

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