Pharmaceutical and therapeutic goods regulatory affairs consulting business based in Australia | Biotech Regulatory Solutions |Biotech Regulatory Solutions | | Pharmaceutical and therapeutic goods regulatory affairs consulting business based in Australia |

Biotech Regulatory Solutions is a regulatory affairs consulting business based in Australia with experienced consultants in most major cities … read more >
Need someone that hits the ground running with your project? Our experienced consultants will keep your project on the move … read more >
We specialise in the Australian Therapeutic Goods Administration (TGA) and New Zealand Medsafe requirements and are up to date with the ANZTPA progression … 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.

Biotech Regulatory Services

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.

Biotech Regulatory Solutions |