CLINICAL
SUPPLY
At G3 Pharmaceuticals, our capabilities offer you full API development and CGMP scale up services for clinical supply material. Our cGMP development facility supports quantities for Phase I studies and our cGMP mini-pilot plant and cGMP pilot plant ensure quantities for Phase II and Phase III trials. So no matter what stage you are at G3 Pharmaceuticals is there for your needs.
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Regulatory requirements, Documentation, Quality Systems are ingrained right from the pre-clinical stage and all our process are tailor-made to suit your needs.
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We ensure that there is the highest level of transparency and quality for you and the regulatory authorities. Our process includes but is not limited to
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Determination of CQAs and CPPs
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Implementation of DoE and QbD techniques
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Preservation of all Data to ensure retrieval at a moments notice