CMOpharma CMC Consultancy Services
CMOpharma has a successful background of outsourcing chemistry development and manufacturing gained over ten years working within pharmaceutical process R&D. Experience of managing the development and manufacture of API's for Phase I and II clinical studies, and support for the necessary regulatory documentation are a key part of our expertise.
In addition to API manufacture, our experience encompasses outsourcing smaller scale projects, including the synthesis of non-cGMP compounds, radiolabelled products and studies of solid-state physicochemical properties.
Chemistry, Manufacture and Outsourcing expertise:
- API manufacture
- Amorphous API development
- Batch documentation review
- Collaborations with contract manufacturers globally
- Due Diligence
- Intellectual Property analysis
- Managing outsourced projects
- Radiochemical synthesis
- Route selection and development
- Small-scale chemistry outsourcing
- Solid-state physicochemical studies
- Specification setting
- Standard Operating Procedures
- Support for Regulatory submissions
- Technical and Service Agreements
- Technical auditing
