Regulatory Affairs and Market Access

Regulatory Affairs and Market Access | TGA Regulatory Affairs Consultants Australia: Adjutor, are specialists in drug development and are able to facilitate and contribute to activities from lab to dossier.

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.

Adjutor are experts in regulatory affairs and market access, able to guide you to market efficiently and effectively in the following areas –


Medicines and medical devices, biologicals, gene and cell therapies, ATMPs


Orbis/ACCESS/Orphan/Provisional/Priority and other expedited pathways


Regulatory agency meeting facilitation USA, EU, UK, CH, AU, JP ++


Risk Management Plans and drafting of product information


Review of websites and social media for compliance


Regulatory due diligence


Regulatory dossier writing, compilation and ePublishing


Evaluation support and product lifecycle maintenance


Pricing, market access and reimbursement submissions


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It’s about telling a true story well.

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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.