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.

Our statistical expertise is perfectly suited for helping you develop and validate analytical methods. We have over 10 years of experience helping laboratory scientists perform varying kinds of physical, chemical, and biological testing. This has included such common analytical technologies as bioassays, immunoassays, chromatography methods, electrophoresis methods, mass spectrometry methods, and absorption spectroscopy methods. No matter what the analytical technology is, we can help you achieve sound performance of your method through any of the following means:

- Experimental design and statistical analysis for method development, transfer, or comparability studies

- Sample size determination, experimental design, and development of appropriate acceptance criteria for method validation

- Statistical process control techniques for the ongoing monitoring of post-validation performance

- Investigative data analysis to identify CAPAs or other opportunities for method optimization

We are your partner in establishing the most robust demonstration that all data generated by your analytical method has been produced in accordance with the method’s intended use(s), and that the method fully complies with applicable regulatory requirements and expectations, pharmacopoeial standards, and your own organization’s validation requirements.

There are challenges in developing new manufacturing processes, analytical methods, and business processes. Then there’s the challenge of maintaining consistent, high quality performance when using them.  We have an array of tools and strategies to help you implement a performance management system that maximizes the benefits yielded by the data from your process.