Galenauxi Ltd

GalenAuxi Ltd is an independent consultancy, providing support to the Pharmaceutical Industry based on a broad expertise (including Pre-Formulation, Solid State Characterisation, Formulation Development and Clinical Trial Product Manufacture, analysis and supply). GalenAuxi Ltd provides tailor made services based on your needs and our experience. Further than just providing advice and thanks to a strong technical experience and a broad network of experts, we can help you plan, outsource and oversee your CMC activities to meet your needs. Typical services include: Clinical trial manufacturing/supply project mapping, due diligence and initiation. CDMO selection process GMP Audit of clinical drug product CDMOs CMC Project management (Prince2® Practitioner certified) Full oversight of CDMO outsourced activities Scientific, Manufacturing or Quality documentation Support with IMPD regulatory CMC section content & Response to Questions (RTQs) from Regulatory authorities CMC Technical support covering: API solid state characterisation, Early stage pre-formulation/material sciences activities, Pre-clinical formulation for early stage models, Analytical testing, specification and stability requirement, Clinical formulation and Clinical Product manufacture based on your API properties and targeted delivery route (e.g. Oral delivery, Dry Powder for Inhalation (DPI) formulation, Parenteral)