apigenex 

For customers requiring assistance with GMP development and manufacturing we can provide a range of GMP-compliant services. We are also now constructing in-house GMP production facilities to expand our capabilities. Currently we offer:

• Process development and validation
• In-house reference standards, preparation and characterization
• Impurity reference standards, preparation and characterization
• Analytical methods, development and validation
• Stability testing
• Generation of all required GMP documentation
• Generation of European DMFs
• Regulatory Support