Clinical Trial Material
The ability to move development stage products into First in Man clinical studies is now a key step in accelerating the development process. To better serve these client needs, Exemplar provides state of the art cGMP clinical supplies manufacturing in Class 100,000 suites for pMDIs, DPIs, nasal and buccal sprays in support of Phase I through Phase IV activities. All processes are carried out in environmentally controlled rooms.
Filling Capabilities
pMDI
- Small (30L) to large scale (250L) pressure vessels
- Manual and semi-automatic Pamasol crimping and filling equipment
- Process development and scale up support
DPI
- Based on the specific inhaler technology chosen, Exemplar will work with the client to develop product- and device-specific filling processes
Aqueous Nasal Sprays
- Semi-automatic filling processes for solution or suspension products
- Manual and semi-automatic filling of single and bi-dose products
Labeling, packaging and assembly services provided
Exemplar is the sole representative of Pharmask, Inc. for their unique line of double blind clinical masking devices. These devices will accommodate most commercial pMDI and nasal spray products. Exemplar provides double blind clinical masking and labeling services for these devices.