Our Services

biotech

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
Biotech Dossier Reviews

Dossier Reviews

Gap Analysis of dossiers and data packages, identifying deficiencies for submissions to TGA and Medsafe
Biotech Specialist services

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.