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Biotech Regulatory Solutions at the ARCS Annual Scientific Conference

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).

USA FDA has accepted Sandoz application for biosimilar filgrastim

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

Biosimilar session at the ARCS Scientific Congress

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

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.