Aptuit | Integrated CMC

Integrated development

In order to develop a novel compound to a safe and effective treatment, a package of studies is required. These study designs need to be tailored for each compound in development. This requirement is partnered with the need for accurate assessment of safety data, confidence in this data, and often requires delivery within tight timescales.

Our integrated approach helps you move through to IND submission smoothly and cost effectively.

Aptuit | Integrated CMC | Integrated development

Our Chemistry, Manufacture and Control group has the expertise and experience to design and execute all of your study requirements and perform them in a single location. 

Our Integrated Development includes: 

API route scouting and process development

API Scale-up and manufacturing

Formulation prototyping and development

Analytical development and QC

Material sciences and pre-formulation

Process/technology transfer

Project management

Quality Assurance