Turn-Key Solutions for your Products
At Apex Labs, we provide a comprehensive, turn-key solution for the development and regulatory compliance of AUST L (Listed) therapeutic products. Our end-to-end service encompasses:
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Product Formulation
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Product Registration
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Labelling Compliance
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Pilot Batch Trials
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Manufacturing Support
Product Development Services
Developing therapeutic formulations can range from simple to highly complex, depending on the nature of the product and regulatory requirements. Apex Labs streamlines the process through a structured framework:
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Concept Development – Identifying the need and potential of the product.
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Feasibility Research – Evaluating technical and commercial viability.
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Clinical Research – Understanding efficacy, safety, and compliance needs.
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Product Development – Creating and refining formulations.
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Proof of Concept – Conducting initial trials to validate formulation stability and effectiveness.
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Final Formulation – Optimizing the formulation for scale-up and stability.
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Data Generation – Collecting necessary analytical, stability, and safety data.
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Regulatory Submissions – Preparing comprehensive documentation for TGA approval.
