Once a lead compound has been identified, the biopharmaceutical development is a long process including preclinical phases and clinical trials to obtain regulatory marketing approval. During this development a variety of analytical technologies are used to assess the characteristics of the product. Many of these methods must evolve into assays that will require validation for their final intended use. Validated test methods are necessary for full compliance with cGMP and GLP regulations.
As the development of your product proceeds, GenoSafe will support your increasing needs for a specific assay method:
- Development from scratch including a feasibility step
- Qualification for early phases
- Validation according to ICH – Q2 (R1)
- Transfer between laboratories
GenoSafe offers its clients an efficient and continuous approach ensuring the appropriate level of development at the right time according to regulatory guidelines.