We are so proud to have received an award from ARCS and voted as “Favourite CRO, Consultancy or Partner – Biotech Regulatory Solutions Pty Ltd”. Thank you to our clients and peers for your support. It has been a great 10 years as a regulatory affairs consulting company, working together to enable medicines (innovative, generic and biosmilars) and other therapeutic goods to become available to Australian & New Zealand patients.
Favourite CRO, Consultancy or Partner – Biotech Regulatory Solutions Pty Ltd
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)