Contract Pharmaceutical Product Development & Manufacturing Process Validation

Lee BioSolutions partners with scientific research organizations and commercial pharmaceutical companies to validate their product design, development and manufacturing processes. We can help your organization create and document processes, remove inconsistencies and ensure that conditions are planned and controlled. Validation services include raw biomaterials and active pharmaceutical ingredients (APIs), instrumentation and calibration, personnel training, as well as physical and environmental conditions. Our validation services will ensure your organization can reproduce your biopharmaceutical products in a consistent, scalable and compliant manner.

We're a Trusted Outsourced Pharmaceutical Product Development Validation Expert

Lee BioSolutions has been a trusted partner to the world's most respected research universities, hospitals and institutions, as well as the industry's largest names in clinical diagnostics, pharmaceutical and biotechnology. They trust Lee BioSolutions because we:

  • Have 35 years of experience in the scientific research, laboratory, diagnostics, healthcare and biopharmaceutical industry.
  • Are ISO 9001:2008 certified, FDA registered and meet USDA and EPA guidelines.
  • Comply with cGMP best practices and utilize industry-recognized standard operating procedures (SOPs).
  • Retain an internal quality control department of experienced scientists and laboratory research personnel.
  • Feature a nearly 20,000-square-foot production and processing facility.