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BioPharma Regulatory Consulting

Ownership: Private
Development stage: Other

Overview

BioPharma Regulatory Consulting specializes in providing Australian-focused regulatory affairs consulting for genetically modified organism (GMO) therapies, including viral vector products. The firm offers end-to-end guidance on classification, writing, review of license applications/exemptions, staff training for clinical trials with GMOs, SOP development specific to GMO trials, OGTR accreditation guidance, and access to an Institutional Biosafety Committee. They also advise on importing GMO therapies into New Zealand.

Modalities: Genetically modified organism (GMO) therapiesGene therapyViral vector products
Industry: Consulting

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