Formulation development for new chemical (NCE) and new biological (NBE) entities and generic OTC and Rx
Optimization of existing formulations
Process development for specific dosage forms
Improving delivery of existing dosage forms
Developing controlled release, sustained release, and complex formulations
Dedicated suites for the handling of DEA Scheduled Compounds
Support of clinical-niche and commercial manufacturing
Our team can offer complete guidance, including from a regulatory standpoint, for the development and manufacturing of your compound. We have a comprehensive and full-service operation for clinical trial materials preparation in support of Phase I – III development as well as for commercial scale-up and manufacturing of solid, liquid, semi-solid and parental dosage forms, sterile and non-sterile. Our services are cGMP compliant and include established protocols, efficient documentation practices, and effective QA management. We can be your greatest resource.