Best in class methodology

Process validation

Commercial success are possible when Manufacturing and cross functional teams produce safe and effective product. Regulatory agencies across the globe would also like to know batch histories to ensure patient safety. It’s inevitable for manufactures to demonstrate the control over the process in time. Rubizon has best in class engineers and scientists who have enjoyed the success at global regulated markets. 

Control strategy

Cleaning validation

Equipment & Software qualification (IQ, OQ & PQ)

Technology transfer

Validation protocol & report

BMR preparation & review

Corporate training

In process stability at scale

Hold time stability at scale

Manufacturing support during validation

Leachable & extractable studies