OUR SERVICES

GalenAuxi Ltd provides tailor made services based on your needs and our experience.​

Further than just providing advice and thanks to a strong technical expertise and a broad network of experts, we can help you plan, outsource and oversee your CMC activities to meet your needs.

Ad-Hoc or Regular Consulting format are possible.

​Please do not hesitate to contact us to discuss your specific requirements.

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Typical services include:

• Clinical trial manufacturing project planning, due diligence and initiation 

• CMC Project management (Prince2® Practitioner certified)

• GMP Audit of clinical drug product CDMOs 

• Clinical Drug Product/Placebo supply chain mapping, selection and oversight

• CMC scientific advice / technical support for:

  • 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 for:

    • Oral delivery​

    • Dry Powder for Inhalation (DPI) formulation

    • Parenteral

    • Other

• Scientific, Manufacturing or Quality documentation

• Regulatory CMC Documentation

  • CTDs (Module 3) for:​

    • IMPD & IND Quality sections​

    • MAA/NDA

    • Variations

  • Dossier vs. QA document gap analysis​

  • CMC Response to Questions (RTQs) from Regulatory authorities

• We can provide you with practical data and interpretation for:

  • Characterisation of your API samples with the following techniques:

    • Powder X-Ray Diffraction (PXRD)

    • Differential Scanning Calorimetry (DSC)

    • Thermogravimetric Analysis (TGA)

    • Dynamic Vapour Sorption (DVS)

    • Solution Calorimetry (SolCal)

    • Optical Microscopy, Scanning Electron Microscopy (SEM)

    • Particle Size Distribution (PSD)

  • Pre-formulation/material sciences activities (early stage):   

    • ​Solubility (Aqueous buffers, solvents or mixture), solution stability

    • ​Crystalinity, ​polymophology, salt screening etc.

    • Photo-stability

  • Formulation for in-vivo pre-clinical models based on API characteristics​