Biotech Regulatory Solutions

Biotech Regulatory Solutions is a scientific affairs consulting business based in Australia with experienced consultants in most major cities

What We Do

We specialise in the Australian Therapeutic Goods Administration (TGA) and New Zealand Medsafe regulatory requirements for all therapeutic goods (medicines and devices), dossier and technical package review to dossier submission, life cycle maintenance, GMP advise, Pharmacovigilance, Medical Information and Quality Assurance.

Our Services

Why Us?

Need someone that hits the ground running with your project? Our experienced consultants will keep your project on the move.

Client Testimonials

Specialist Services

Biotech Regulatory Solutions Services include: 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.

Dossier Reviews

Gap Analysis of dossiers and data packages, identifying deficiencies for submissions to TGA and Medsafe, Submission pathway options, Biowaivers. Submission pathway options, biowaivers

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, Priority Review/Designation, Provisional Registration.

Comparable Overseas Regulator (COR) pathway and Abbreviated submission pathways, Pre-Submission meetings and Liaison with the Authorities, in Australia assistance with Priority Review/Designation, Provisional Registration and Comparable Overseas Regulator (COR) pathway, in New Zealand assistance with Priority and Abbreviated pathway options.