Your partner in regulatory affairs.
Pharma To Market provides global regulatory support services and outsourcing solutions to the pharmaceutical industry. Based in Australia, we are unique in that we offer regulatory and technical support for submissions in key global markets including Australia, New Zealand, USA, Europe, Canada, and South East Asia.
Pharma To Market are licensed vendors of the Regulatory Solutions Suite (RSS) of software from ISI. We offer full implementation and maintenance services to companies in Australia and New Zealand for ISI's Regulatory Solutions Suite including eCTDXPress, ISIWriter, ISIToolBox and ISIPublisher. Pharma To Market also offer complete outsourcing solutions for eCTD and paper publishing.
Contact us today to discuss how Pharma To Market can assist your company with eCTD solutions and regulatory affairs consulting. At Pharma To Market we believe in helping our clients realise their products’ global potential. Our clients benefit from liaising with only one company for submission of their product in key global markets. This quality promotes the formation of a clear and successful global regulatory strategy, incorporating:
Timely submission preparation and life cycle management
Our expertise in the global regulatory market ensure our clients make informed choices and hold realistic expectations from submission through to approval and life cycle management. Seamless adaption of dossiers for submission in multiple regions provides a cost effective solution without comprimising on quality or expediency.
Identification of data requirements for key markets
Whilst the format of regulatory submissions is largely harmonised (CTD), the content requirements differ from region to region. Using our expertise we can help you identify and distinguish between global and regional requirements, both regulatory and technical, and how best to satisfy these in your development plan.
eCTD implementation and outsourcing with ISI's RSS
ISI's Regulatory Solutions Suite (RSS) is a fully integrated solution with the functionality to create any submission format. Enjoy the benefits of Pharma To Market's local support for eCTD implementation and outsourcing solutions backed by ISI's market leading products and global network.
Pharma To Market Pty Ltd
ABN 13 135 064 078