Biotech Regulatory Solutions |

Biotech Regulatory Solutions |

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

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Biotech Regulatory SolutionsAustralia & New Zealand (ANZ)

Therapeutic Goods Administration (TGA)

Medsafe

Australian New Zealand Therapeutic Products Authority (ANZTPA)

Australian Quarantine and Inspection Service (AQIS)

ARCS Australia

USA

Food and Drug Administration (FDA)

Europe

European Medicines Agency (EMA)

Medicines and Healthcare Products Regulatory Agency (MHRA)

Canada

Health Canada

Singapore

Health Sciences Authority

Global

World Health Organisation (WHO) Pharmaceutical

Inspection Cooperation Scheme (PIC/S)

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.

Latest news

  • Management and communication of medicine shortages and discontinuations in Australia
  • TGA Issues new Therapeutic Goods Order – TGO 101 (Standard for tablets, capsules and pills)
  • TGA has posted Important Dates for Sponsors of therapeutic goods for fees (Annual fees, exemptions)
  • Favourite CRO, Consultancy or Partner – Biotech Regulatory Solutions Pty Ltd
  • ARCS Annual Conference – Sydney 2017
  • TGA Pharmacovigilance Inspections – starting 2017
  • TGA Regulatory Affairs Consultants
  • Australia’s 1st monoclonal antibody biosimilar approved by the TGA

Stay in touch

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Contact Us

Katy King – Principal Regulatory Affairs Consultant & Managing Director

P: + 612 9979 3700
E: katy@biotechregulatory.com.au
M: +61(0) 409 747 074
A: PO BOX 51, Church Point, NSW, 2105, Australia

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