Synthesia Research

PROCESS DEVELOPMENT

The Process Development section of Synthesia Research includes activities addressed both to manufacturers of fine chemicals in bulk and medical/pharmaceutical companies. It could provide experimental studies about development, optimization and scale-up of chemical processes which from the stage of discovery need to be inserted in a wider context.

In compliance with the increasingly and sophisticated requests of control health authorities, such as FDA, which forces manufacturers of drugs and APIs to recognise the relative substances of their products and to provide as well the appropriate samples, Synthesia Research carried out the study, the identification and preparation of found and potential impurities arising from synthetic procedures.

Synthesia Research offers services of:

• definition and constituency of critical parameters of synthetic process
• optimization and industrialization of the synthetic procedure
• study and development of "in continuous" synthetic processes
• validation of synthetic process
• development and validation of analytical methods of the "in-process" intermediates
• scale-up of synthetic procedure
• preparation of working standards
• preparation of potential/found impurities
• preparation of samples or small batches of product until 100g (for greater quantities we stipulate collaboration agreements with pilot plants selected by us, that can operate under our supervision)
• drafting of "Development Reports".