Clinical Trial Materials

Bridging the Laboratory and Your Market

DPT will expedite your drug development program through effective, efficient production of clinical trial materials. Our formulation scientists and manufacturing teams work directly with you and/or your contract research organization (CRO) to assist with technology transfers for later-phase clinical trial materials, registration batches and commercial launch.

DPT’s integrated services and in-depth experience with technology transfers ensure that clinical trial manufacturing processes pass seamlessly to commercial-scale production. We have extensive experience in handling the development and cGMP manufacturing of inhaled products, liquids, lotions and many other dosage forms. Additionally, we provide packaging identification, compatibility assessments and other related tasks, as well as scale-up estimates when your product moves into commercial cGMP manufacturing.

CLINICAL TRIAL MATERIALS SOLUTIONS

  • Phase I-III registration batches and commercial launch
  • cGMP batch sizes from 0.3 kg
  • Extensive packaging capabilities

To simplify your pathway to approval, we provide regulatory submission support, such as chemistry, manufacturing and control (CMC) services for investigational new drug (IND) applications. And our regulatory and clinical trial manufacturing teams work closely to ensure efficient, accurate submission of a detailed CMC filing for the IND.