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

Project Management, Literature based submissions, Biosimilar applications, Orphan drug designation applications, Local sponsorship/Marketing authorisation holder, eCTD and NeeS, Medical Information, Pharmacovigilance