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)
Company Details
- Founded
- -
- Address
- Fleet
- Industry
- Pharmaceutical Manufacturing
- NAICS
-
Pharmaceutical and Medicine ManufacturingMedicinal and Botanical ManufacturingPharmaceutical Preparation ManufacturingIn-Vitro Diagnostic Substance ManufacturingBiological Product (except Diagnostic) Manufacturing
- Website
- galenauxi.co.uk
- HQ
- Fleet
Galenauxi Ltd Questions
Galenauxi Ltd's website is galenauxi.co.uk
Galenauxi Ltd's LinkedIn profile is https://uk.linkedin.com/company/galenauxi-ltd
Galenauxi Ltd's industry is
Pharmaceutical Manufacturing
Galenauxi Ltd's categories are Pharmaceutical Manufacturing
Galenauxi Ltd's founding year is 2016
