We have been heavily involved in developing regulatory support data for a nicotine delivery product which has been submitted to the MHRA for consideration, and are part of the analytical team to be licensed to carry out product release.
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Clinical Dose Formulation
Method Development, Validation And Verification
We can support by detailing the process to generate final clinical trial dose forms before releasing them to a cGMP facility for manufacture.
During this phase of manufacture we can help in establishing and verifying many of the practical activities including preparing powder blends, simple tableting, and low volume capsule filling as well as preparing solutions, suspensions and creams. For solid dose forms we can also assess dissolution, powder flow, friability, disintegration, density and similar characteristics. For liquids and creams we can assess viscosity and density. We also have the capability for mapping final dose forms for API dispersion by Raman Microscopy.
At this stage, particularly if a solid dose form is involved, we can help by assessing metal contamination levels in the formulation. We can also support with more dose specific assessments, for instance for pulmonary products we have a Sympatec Particle Sizing-Inhaler combination to rapidly provide discriminatory data considering different inhaler devices. We can also provide Anderson Cascade and Next Generation Impactor analytical support for use once a particular device has been selected. A detailed technology transfer package and support will be provided so that a cGMP manufacturing facility will be able to carry out all aspect of the work developed at Agenda1.