Shanghai Bailun Biotechnology Co., Ltd.
Services
Verification Services
Bailun provides validation services covering the entire life cycle of R&D, production and marketing in the biopharmaceutical field, and builds a comprehensive compliance validation system from process development, facilities and equipment to computerized systems. Relying on the global mainstream regulatory framework (FDA 21 CFR Part 11, EU GMP Annex 1, etc.), we systematically link CQAs and CPPs through the three pillars of process validation, equipment validation and cleaning validation, complete dynamic environmental monitoring, computerized system audit tracking validation and compliance design of aseptic production scenarios, and reduce technology transfer deviations and regulatory audit risks. We simultaneously output validation master plans (VMPs) and structured electronic validation packages (eVPs) that meet the regulatory requirements of multiple countries; for the high-risk biological preparation field, we customize toxicological residue limit assessment models and production facility validation solutions, and provide end-to-end services from compliance gap analysis, agile validation execution to continuous change management. Bailun enables enterprises to build seamless compliance from micro parameters to macro systems through knowledge transfer and full-process document support from a global team of experts, providing continuous protection for biopharmaceutical quality and safety across the life cycle.
Shanghai Bailun Biotechnology Co., Ltd.
Liu Xiang Road 6848， Hua Ting Town, Jiading District, Shanghai
E-mail：15821268711@163.com
