We are so proud to have received an award from ARCS and voted as “Favourite CRO, Consultancy or Partner – Biotech Regulatory Solutions Pty Ltd”. Thank you to our clients and peers for your support. It has been a great 10 years working together to enable medicines (innovative, generic and biosmilars) and other therapeutic goods […]

Biotech Regulatory Solutions chaired a session at the ARCS Sydney Annual Conference 2017  “A Case Study Using Novel Scientific Technologies to Mitigate Risk in Drug Development” with Speaker Daina Vanags PhD. “…With the advancement of technologies such as induced pluripotent stem cells (iPSCs) regulators are highlighting concepts such as “Clinical trials in a dish” whereby […]

The TGA has released two consultation guidance documents to industry on the soon-to-be implemented Pharmacovigilance(PV) Inspection programme applicable to the Australian therapeutic industry. The TGA are conducting workshop sessions in 3 major cities TGA Pharmacovigilance Inspection Program: Information Sessions. Please contact Biotech Regulatory Solutions to discuss your companies needs and readiness for TGA PV Inspections. We […]

Biotech Regulatory Solutions has a team of  highly experienced and leading therapeutics industry professionals covering Regulatory Affairs, Quality Assurance, Pharmacovigilance, Promotional Material review, and Medical Information services.  Our consultants are based in Sydney, Brisbane, Melbourne and Singapore. Our team are all leading professionals in the therapeutics industry with experience ranging from 15 years to over […]

TGA has approved Australia’s 1st monoclonal antibody biosimilar INFLECTRA infliximab (rmc) 100mg Powder for Injection vial, a biosimilar medicine. On the ARTG 19th August 2015.

Biotech Regulatory Solutions chaired a session at ARCS Annual Scientific Conference in Sydney May 2015 on Extrapolation of Indications for Biosimiliars Key note speaker from the Therapeutic Goods Administration (TGA).

Biotech Regulatory Solutions presented and chaired at a session at ARCS Annual Scientific Conference  in Sydney May 2015 on Literature Based Submissions (LBS the Options and the Lessons) Key note speaker from the Therapeutic Goods Administration (TGA)

Biotech Regulatory Solutions presented at a session at ARCS Annual Scientific Conference in Sydney May 2015 on Module 3 requirements for biologics Key note speaker from the Therapeutic Goods Administration (TGA).

On the 24th July 2014 Sandoz announced that the USA FDA has accepted Sandoz application for biosimilar filgrastim.

Biotech Regulatory Solutions are chairing a biosimilar session at the ARCS Scientific Congress in Canberra September 2014