At DataPharm we use engineering and statistical principles to help you completely define your process design space and implement operational improvements that reduce cost, improve product quality, and increase production capacity. Whether you’re producing solid oral dosage forms, liquid dosage forms, sterile injectables, or biologics, our statistical expertise helps you accomplish your objectives in each of the following aspects of commercial manufacturing:
process characterization studies
process validation
continued process verification (post-validation)
process optimization
technology transfer activities
In addition to the above, our statistical expertise can be leveraged to support your investigation and resolution of complex commercial manufacturing issues, including the development of appropriate CAPAs and effectiveness review criteria.