We provide consultation to biologics, Vaccines, Biodrugs, Pharmaceuticals the entire Product Lifecycle development to management for US-FDA & EMEA.

Technical Operations Commercial manufacturing Quality operations (QC, QA< Validation, Tech Services) Six Sigma Black belt & Lean & Design for Six Sigma Technology transfer, Analytical methods development, validation Reference reagents Characterization and Qualification Clinical Trials Immunogenicity test CGLP Tox studies design & execution CGLP methods development cGMP Manufacturing Biosimilar development from Research to Launch CMC Regulatory writing, IND, NDA, eBLA, eCTD, ANDA fili...

Technical Operations Commercial manufacturing Quality operations (QC, QA< Validation, Tech Services) Six Sigma Black belt & Lean & Design for Six Sigma Technology transfer, Analytical methods development, validation Reference reagents Characterization and Qualification Clinical Trials Immunogenicity test CGLP Tox studies design & execution CGLP methods development cGMP Manufacturing Biosimilar development from Research to Launch CMC Regulatory writing, IND, NDA, eBLA, eCTD, ANDA filing and Negotiations with regulators Clean, Equipment, Process, 21 CFR protocols, Validation execution, Reports Site Master Validation SOPS, QA SOPS, QC SOPS, The entire R&D to Process/Product development for Live Viral & Bacterial, Conjugated Vaccines, r-DNA therapeutic proteins, Monoclonal Antibodies