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.

Facilitating your path
to approval and launch
in multiple countries

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

Good content isn’t just about good storytelling.
It’s about telling a true story well.

Ann Handley

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.

Let’s talk