Formulation Research Development​

Formulation and process development are key processes to achieve the best drug product possible. Both processes are required to control the drug product to the needed quality attributes so that each commercial batch is saleable.

• Formulation development involves both sourcing the most appropriate grade materials tailored for product design and assessment of the drug within the formulation. The reverse engineered formulation is used to assess the drug-excipient compatibility, initial stability and develop specifications.
• Our Process Development strategy deploys a systematic Design of Experiments (DoE) approach to how the product will be made which can be translated to scale at the manufacturing site of your choice. Deploying a Quality by Design (QbD) approach for all avenues of our development program, we ensure that the Critical Quality Attributes (CQAs) are controlled to optimize batch success rate and to be ready for your regulatory dossier. With a full understanding of current cGMP standards, the process development team can support many dosage forms, drug-device combinations and packaging configurations.
• Scale-Up Support W We also have a wide network of established manufacturers of various dosage forms we can recommend and engage, should you require help with.