TGA has been a partner in Project Orbis from 2019 an initiative of the FDA’s Oncology Centre of Excellence. Collaborative review by partner regulatory agencies.
https://www.tga.gov.au/project-orbis
TGA has been a partner in Project Orbis
Biotech Regulatory Solutions
Liaison with the Authorities – TGA and Medsafe, Prescription medicine registration, Biotech medicine registration, Biosimilar medicine registration, Generic medicine medicine registration, OTC medicine registration, Medical Device registration and inclusion, Literature Based Submissions, Dossier reviews and gap analysis reports, Pre-Submission meetings with the TGA and Medsafe, Regulatory affairs consultants and training Australia, Regulatory affairs consulting firm, leading TGA Consultants Sydney, Brisbane, Melbourne, Singapore, Pharmacovigilance, Medical Information, Quality Assurance, Audit Inspection readiness (GMP and Pharmacovigilance), GMP.
Latest News
- TGA has been a partner in Project Orbis
- TGA Summary of the regulation of Personal Protective Equipment and COVID-19
- TGA Priority Review for Prescription Medicines
- TGA Issues new Therapeutic Goods Order – TGO 101 (Standard for tablets, capsules and pills)
- TGA has posted Important Dates for Sponsors of therapeutic goods for fees (Annual fees, exemptions)