B2S Consulting

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CMC Support

Clinical Trials Statistics & Outcomes Research Analysis of Observational Data Drug Safety - Demonstration of Risk vs. Benefit Incremental Cost-Effectiveness (ICE) Analysis PK/PD Support Statistical Analyst & Programming Support Statistical Support for all phases of Clinical Trials	Bioanalytical & Ligand Binding Assays Bioanalytical Statistics & Design-of-Experiments (DOE) CRO Lab Selection & Bioanalytical Life-Cycle-Management Ligand Binding Assays Method Validation	Protein / Peptide Therapeutics & Biosimilars ADME of Protein / Peptide Biotherapeutics Biosimilars / Biocomparables Insulin / Insulin Analogues LC-MS Analysis PK Data Analysis Preclinical Toxicology / IND Support

Immunogenicity, Immune Safety Testing, & Risk Assessment & Mitigation Anti-Drug Antibody (ADA) Assay Development & Validation Preclinical / Clinical Immunogenicity Risk Assessment & Mitigation Planning Preclinical Safety Testing / Immunotoxicology Statistics for Screening & Confirmatory Cut-Points	CMC Support Manufacturing & Regulatory Support Preformulation, Formulation, & Analytical Methods Dev.	Clinical Drug Development, Pharmacokinetics & Modeling, & Regulatory & Quality Audit Conduct & Responses Clinical Drug Development Clinical Pharmacology, Pharmacokinetics & Modeling GLP Compliance - SOPs, Quality Reviews and System Validations Regulatory Sciences Technical Writing

B2S Consulting™