Adjutor Healthcare
Adjutor Healthcare partners with businesses to bring new medicines and medical devices to market. We focus on regulatory strategy, product registration/ lifecycle management, quality/QMS, market access, distribution and commercialisation so your innovation can reach the people who need it most.
At Adjutor Healthcare, we specialise in bridging the gap between innovation and impact. From navigating complex regulatory requirements to developing market access and commercialisation strategies, we work with you to ensure your medicines and medical devices reach the people who need them.
Now that your product has been developed, we can help you to you access a wide variety of countries and ensure effective commercialisation and product launch strategies.
Through our extensive networks of Partners we can provide in-country caretaker, Marketing Authorisation Holder, Regulatory Agent and Sponsor services for clinical trials, regulatory submissions and, in many cases, also for marketed products.
– North and Latin America
– Europe/UK
– Asia/Pacific
– Middle East
Planning for commercialisation happens in parallel with regulatory activities and can be just as complex. Adjutor consultants know the processes well and provide local knowledge in primary, secondary and tertiary markets.
Our team can help you with –
Sponsorship/Agent for applications and marketed products
Introduction to distributors and logistics providers
Local release for distribution of marketed products
Pharmaco- and device vigilance
Review of product promotional materials for compliance
Review of websites and social media for compliance
Import/Export permits
Wholesale and other special licences
Benefits of Product Registration in Australia
- International Harmonisation: The Therapeutic Goods Administration (TGA) follows ICH Guidance and is also a member of PIC/s. The TGA also participates in multiple international collaborations and work-sharing initiatives, such as Project Orbis and the ACCESS Consortium.
- Recognition: The TGA is a widely recognised regulatory agency. Approvals of medicines and medical devices in Australia can facilitate approval in other countries.
- Special Pathways: TGA has an orphan drug designation program, together with Priority and Provisional pathways for innovative medicines. Expedited reviews for biologicals and medical devices are also available in some cases. TGA also has abbreviated review pathways, based on approvals in other recognised jurisdictions.
- Access to Feedback: TGA pre-submission meetings are fee free and can provide valuable insights into issues that may arise with other agencies, including EU/UK and North America.
Your brand is what other people say about you when you’re not in the room.
Jeff Bezos
Ready for growth?
Contact us today and let’s work together to achieve your goals. Whether you have a question, need more information, or want to discuss your project, our team is here to help.