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.

Katy King – Principal Regulatory Affairs Consultant & Managing Director

P: +612 9999 4770
E: katy@biotechregulatory.com.au
M: +61(0) 409 747 074
A: PO BOX 51, Church Point, NSW, 2105, Australia