Australia: Are you ready for eCTD?

eCTD Implementation, Software-as-a-Service (SaaS) & (e)Submissions Outsourcing
Strategy, Project Planning & CMC Consulting
Solutions and Training for global regulatory affairs


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eCTD solutions

In order to achieve the best eCTD solution for your company there are many factors to consider: balancing the cost of eCTD software, staff training and IT support with Software-as-a-Service (SaaS) and outsourcing options to name a few. Contact us to discuss the range of options available to best suit your business needs. Whether implementing a full scale internally hosted solution or outsourcing your entire submission - Pharma to Market can help. Companies in Australia and New Zealand benefit from Pharma to Market’s local support backed by ISI’s extensive experience and global network.

eCTD Submissions Outsourcing

Pharma to Market understands that many companies are better positioned to outsource submission processing than to immediately purchase all of the technology needed to prepare eCTD submissions independently.

Pharma to Market offer outsourcing services for all aspects of paper and electronic document compilation, preparation, and assembly using the Regulatory Solutions Suite (RSS) of software from ISI. eSubmission outsourcing formats are fully validated and compliant and include appropriate navigational aids. We can help with scanning, clean-up, submission assembly and content tracking in all current submission types and structures (including conversion of legacy documents in to eCTD acceptable formats), submission publishing (paper and electronic) through to final agency submission. Contact us for more information on eCTD submissions outsourcing.

Software-as-a-Service (SaaS)

Software-as-a-service (SaaS) provides a cost-effective alternative over traditional purchasing of software applications without compromising on meeting business objectives. Receive fully accredited training on ISI’s RSS and use applications on a "pay as you go" basis. Benefit from immediate access to all the features and functionality of the RSS, whilst reducing upfront costs. The software is hosted externally in a secure and validated environment and is fully compliant with FDA’s 21 CFR §11 and the EC’s Eudralex Volume 4 Annex 11. Contact us for more details on SaaS.

Software Implementation and Maintenance

Pharma to Market offer implementation services for ISI’s RSS software applications for internally hosted solutions. These include pre-implementation gap analyses, on site installation and configuration of any one of ISI’s RSS applications and validation services (creating and executing test scripts, writing validation protocols and reports and complying with customer QA standards etc.). Effective post implementation software maintenance and product support ensures problems are diagnosed and solved expediently and updates are readily available for installation.

Contact us for more information on implementation of the software applications in ISI’s Regulatory Solutions Suite.

eCTD Education:

Pharma to Market are pleased to offer ISI’s fully accredited education courses to companies in Australia and New Zealand. Instructor led software courses and workshops can be conducted on site or remotely. Click here for more information on ISI’s education courses.