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eSubmission Compilation

eCTD System Consultancy

eCDT Training

Document Submission Readiness

EDMS Consultancy

Risk Management Plan (RMP)

Veterinary e-submission


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eSubmission Compilation

Our experienced team will assist you with your Operational eCTDs, NeeS, or other electronic submission tasks and help you navigate in the eSubmission guideline jungle, ensuring that your valid submission will be delivered on time to the authorities. We also offer to support and/or participate in agency meetings and discussions regarding your eCTD.

Submissions can be delivered in any format: electronically with XML (eCTD), NeeS, volumised PDF(s), paper or hybrids according to client and relevant health authority requirements.

Our track record demonstrates the ability to understand the unique compliance issues associated with each dossier format, and we always deliver an end product that meets and often exceeds our client's expectations.

eCTD System Consultancy

The responsibility of deploying a new eCTD publishing system or upgrading an existing system can prove exciting, challenging and even overwhelming depending on the resources available to execute such an assignment.

@ PeC we realize that system implementation is much more than installing a suite of tools or software. Our practical and hands-on experience represents over a decade of knowledge gained from working in the industry.

We possess a good understanding of the daily tasks and standard processes that a Regulatory Department may encounter regardless of organizational size and/or budget.

And we are adept at customizing any plan to meet the unique needs of our clients. Let our eCTD implementation consultants' partner with you to successfully plan out and execute all of the inter-related tasks to achieve your desired results.

eCTD Training

There can be many reasons for performing eCTD training!

Some of our clients may desire a better understanding of the concept eCTD, some need to decide whether to in-house or outsource the eCTD assembly.

Other companies have requested PeC to explain the need for eCTD to their senior-level or executive management team, in order to raise awareness or generate endorsement for an eCTD project.

 

Document Submission Readiness

A large proportion of the time spent on creating eSubmissions, is focused on making the documentation electronically submission ready.

The technical validation of an eCTD considers that the documents are converted to Portal Document Format (PDF) and that the document settings and the navigational items such as table of contents, bookmarks and hyperlinks all are set to the required values.

You can either let us do it for you, or we can offer you training in how to prepare the documentation yourself.

Considering how to make your documents submission ready is time well spent and should be addressed as early as possible. Establishing consistent standards and instructions that are reflective of the eCTD specifications can be of tremendous value to the authors.

When executed efficiently, submission readiness can result in lowering the overall project time thereby producing significant savings in delivering the dossier to the health authorities.

EDMS Consultancy

The documents used to support marketing applications can be excessive especially if considering the editorial modifications that occur during the authoring and review phases. One solution to manage version control and assign systematic organization to each file is through the establishment of an Electronic Document Management System (EDMS).

Our industry experience covers the entire spectrum of working in an EDMS environment from daily users to system's and thesaurus' administrators. While System implementation remains a key component in achieving a document management system, our experience has shown us that the real success for an EDMS lies within the people and processes.

It is important to consider how the EDMS will meet your needs in areas such as indexing, storage, retrieval, security and distribution. Communicating EDMS technical aspects into meaningful everyday work practices for our client's is an attainable objective with the right guidance. We offer our services in connection with implementation, globalization and system upgrade.

Risk Management Plan (RMP)

As of 1 May 2010 only XML files, generated by Visual Basic Form version 3, will be accepted as EU-RMP Annex 1.

We have the tool and expertise to convert your EU-RMP Annex 1 to the in EU required XML file.

The EU-RMP Annex 1 shall reflect the final version of the EU-RMP as agreed at the time of the initial CHMP Opinion and any following CHMP Opinions referring to updates to the EU-RMP.

The electronic submission to EudraVigilance is due within 15 calendar days after the publication of the European Commission Decision (for new marketing authorisations and updates in the context of line extensions) or 15 calendar days after the receipt of the CHMP Opinion (for all other updates to the EU-RMP).

Veterinary e-submissions

Our experienced Veterinary will assist you with your operational Veterinary e-submission tasks. She will guide you through the e-submission guideline jungle, and ensure that your valid submission will be delivered on time to the authorities.

We can also offer to support and/or participate in agency meetings and discussions regarding your submission.

Submissions can be delivered in any format: VNeeS (EU), via Veterinary e-Submitter (US), volumised PDF(s), paper or hybrids according to client and relevant health authority requirements.