BIOREGULATORYCONSULTING.COM.AU

Bio Regulatory Consulting

61 3 9013 8531. In the development and registration of biopharmaceuticals. Bioregulatory Consulting (BRC) is based in Melbourne, Australia and has provided a specialised regulatory and development consultancy service to the biotech and pharmaceutical industry since 2002. Bioregulatory Consulting’s purpose is to enable the entry of new medicines into the marketplace to facilitate better health outcomes for patients. BRC has expertise in development and registration of the following therapies:.

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Bio Regulatory Consulting | bioregulatoryconsulting.com.au Reviews

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61 3 9013 8531. In the development and registration of biopharmaceuticals. Bioregulatory Consulting (BRC) is based in Melbourne, Australia and has provided a specialised regulatory and development consultancy service to the biotech and pharmaceutical industry since 2002. Bioregulatory Consulting’s purpose is to enable the entry of new medicines into the marketplace to facilitate better health outcomes for patients. BRC has expertise in development and registration of the following therapies:.

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Bio Regulatory Consulting | bioregulatoryconsulting.com.au Reviews

https://bioregulatoryconsulting.com.au

61 3 9013 8531. In the development and registration of biopharmaceuticals. Bioregulatory Consulting (BRC) is based in Melbourne, Australia and has provided a specialised regulatory and development consultancy service to the biotech and pharmaceutical industry since 2002. Bioregulatory Consulting’s purpose is to enable the entry of new medicines into the marketplace to facilitate better health outcomes for patients. BRC has expertise in development and registration of the following therapies:.

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bioregulatoryconsulting.com.au

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Bio Regulatory Consulting – Penny Field

http://bioregulatoryconsulting.com.au/author/admin

61 3 9013 8531. Updated TGA Guideline on the Regulation of Biosimilars. The TGA has recently released their updated guidance on the ‘Regulation of biosimilar medicines’ v 2.0, Dec 2015. A few preliminary thoughts:. The section on Reference Medicines has been updated. In order to register a biosimilar in Australia the reference product must be a biological medicine which is registered in Australia on the basis of […]. January 22nd, 2016. More specific requirements for immunogenicity assays. The Trans-Paci...

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Bio Regulatory Consulting – Blog

http://bioregulatoryconsulting.com.au/blog

61 3 9013 8531. Updated TGA Guideline on the Regulation of Biosimilars. The TGA has recently released their updated guidance on the ‘Regulation of biosimilar medicines’ v 2.0, Dec 2015. A few preliminary thoughts:. The section on Reference Medicines has been updated. In order to register a biosimilar in Australia the reference product must be a biological medicine which is registered in Australia on the basis of full quality, safety and efficacy data. The use of reference […]. January 22nd, 2016. A stepw...

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Bio Regulatory Consulting – About us

http://bioregulatoryconsulting.com.au/about-us

61 3 9013 8531. Penny Field presenting on biosimilars at the 2nd Pharmaceutical Regulatory Conference 24-28 March 2014, Beijing, China. Penny Field B.Sc., (Biol.), Hons., (Biotech.), MMedSc., (Drug Development). Jenkins and Jenkins Ltd. Leys Barn, The Leys,. Suffolk, IP30 9PR,. The presentations included covering the topics of drug candidates, safety considerations, other important considerations, transition from discovery to development, preparation of a drug development plan, target product profile, re...

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Bio Regulatory Consulting – Services

http://bioregulatoryconsulting.com.au/services

61 3 9013 8531. Bioregulatory Consulting is uniquely positioned to provide advice on regulatory strategy for early stage development to ensure that all aspects are considered and the best approach to risk mitigation taken. We recognize issues, which can be problematic for the later stages of either out-licensing or registration, and provide quality advice to expedite drug development. Bioregulatory Consulting (BRC) provides consultancy services to the biotech and pharmaceutical industry to assist with:.

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Bio Regulatory Consulting

61 3 9013 8531. In the development and registration of biopharmaceuticals. Bioregulatory Consulting (BRC) is based in Melbourne, Australia and has provided a specialised regulatory and development consultancy service to the biotech and pharmaceutical industry since 2002. Bioregulatory Consulting’s purpose is to enable the entry of new medicines into the marketplace to facilitate better health outcomes for patients. BRC has expertise in development and registration of the following therapies:.

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