Biotech Regulatory Solutions is a regulatory affairs consulting business based in Australia with experienced consultants in most major cities … read more >
Our Services

TGA & Medsafe Submissions
Regulatory Affairs consulting, Prescription medicine registration, Biotech medicine registration, Biosimilars medicine registration, Generic medicine registration, Literature Based Submissions, Over the counter medicine registration, Medical devices (Class I-III) registrations and inclusions

Dossier Reviews
Gap Analysis of dossiers and data packages, identifying deficiencies for submissions to TGA and Medsafe

Specialist Services
Medical Affairs, Scientific Affairs, Promotional Material review, Pharmacovigilance (PV) gap analysis/ inspection-audit readiness reports and solutions, Good Manufacturing Practise (GMP) consulting, Quality Management System consulting, Wholesaling/Distribution consulting, vendor audits and general Quality Assurance.