About
BioCMC Consulting Ltd provides CMC consultancy services to the biotechnology and pharmaceutical sector. Consultancy services can be provided as an interim resource to start-up/established companies prior to the recruitment of a permanent team or on ad-hoc/ongoing basis to provide additional resource or expertise for specific projects or activities.
Particular areas of expertise include:
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CMC development and regulatory strategy for AAV gene therapies, including authoring of CMC regulatory documentation
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Oversight of outsourced GMP services including manufacture, testing and secondary packaging/labelling/clinical distribution
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Parenteral product development and manufacture (fill/finish) including lyophilisation



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