Our drug product consulting services span CMC, Clinical Pharmacology and DMPK. This ranges from input at the pre-clinical \/ discovery phase, through first-in-human (FiH) and early clinical trials (CTs) and onwards to product approval.<\/p>\n
Chemistry Manufacturing and Controls (CMC)<\/strong><\/h4>\n
Our CMC capability covers both drug substance and drug product development. Specific activities include:<\/p>\n
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Drug substance project strategy development and integration with drug product, safety and clinical planning<\/li>\n
Expertise in chemical development at the Discovery interface, Preclinical and Clinical Development, including synthetic route design, process design, solid form selection and analytical method development<\/li>\n
Definition of drug product (formulation strategy) through FiH\/early CTs, Phase 2, Phase 3 and Launch, using rapid prototyping, in-silico formulation tools and product design thinking<\/li>\n
Management and delivery of pharmaceutical development elements of drug development programs (including estimation of costs, timings and resource requirements)<\/li>\n
Design of CMC programs based on the latest Quality by Design thinking<\/li>\n
Definition of Quality Target Product Profile (QTPP) and Quality Risk Assessment (QRA) as per ICH Q9<\/a><\/li>\n