Products for clinical use are a valued component of Ben Venue's business. They receive the same treatment as full-scale production items.

Your clinical batch will:

• Be produced according to cGMP
• Receive the same full documentation that a production batch receives
• Be produced on the same equipment, using the same validated processes as a production batch
• Be handled by the same personnel as a production batch

The only difference between clinical and production manufacturing at Ben Venue is scale. Other contract manufacturers refer clinical manufacturing to Ben Venue because of our willingness to do small-scale batches. Large ethical pharmaceutical companies contract with Ben Venue to manufacture their clinical batches because they lack the facilities for small-scale production. Furthermore, we can provide end product more quickly than their internal manufacturing.

We offer a wide range of batch sizes with fill volumes from 0.5mL to 100mL. Stability testing can be performed on clinical products that we have produced. We also can help you with labeling and final package designs.

Clinical Manufacturing at Ben Venue Laboratories

Product and Process Development
Pre-IND Clinical Manufacturing

For animal toxicity studies
For chemical stability studies

Typical batch size up to 1,000 units

IND Phase I

For efficacy testing
For dosage- range finding

For human safety studies
For drug stability studies

Typical batch size up to 5,000 units

IND Phase II

For expanded clinical studies
For investigation of specialized delivery systems

For finalization of dosage form for market
Typical batch size up to 10,000 units

IND Phase III

For expanded clinical studies
For final development of label claims

For final development of contra-indications
For additional supplies required for compassionate use

For process validation
Typical batch up to 100,000 units

NDA Submission