Chemistry Manufacturing & Controls

CMC Support for preIND and IND enabling studies

Ab Initio specialises in establishing R&D packages that support investigational new drug applications. Following regional guidelines we can provide bespoke testing services that support documentation packages used in the registration of new medicines. These include:

• Establishing Target Product Profile and Specifications

• Assay and related substance analysis

• Product delivery characteristics

• Solid state stability profile

• Chemical stability profile per ICH guidlines

• Extractables and Leachables

• Product Robustness

• Packaging considerations and compatibility