Quality Systems has the experience to develop solutions for cutting edge products, focusing on total quality management and compressing development timelines. Products Pharmaceuticals Fusion Proteins Monoclonal Antibodies Sterile Injectables Suspensions API Conjugates Peptides Nano-engineered drugs Xenotransplant products Cell Therapies Quality Systems Quality Programs Development Risk Assessment and Risk Management Effective Quality Roles Supplier Qualification Processes, Systems, Facilities Laboratory Controls Systems Critical Systems and Engineering Design Control Drug Master Files (Facility and Product) Facility Master Validation Plans Quality Systems Gap Analysis Active Ingredients Finished Products Devices and Combination Products Cell- and Tissue-Based Products Pre-Approval Inspection Preparations Quality System Regulations Good Tissue Practices Good Laboratory Practices Good Clinical Practices Good Manufacturing Practices Corrective and Preventative Action Programs Trend Analysis and Reporting Stability Program Assessments Facility Design and Equipment Qualification Master Validation Planning Facility Design, Engineering, Requirements and Specifications Process Flow and Design Cleanroom and Environmental Monitoring Flow of Materials, Equipment and Personnel Equipment Installation, Operation, and Performance Qualification Engineering Build Reviews and Assessments Active Pharmaceutical Ingredient Facilities Biological Product Facilities Commissioning and Qualification Product and Method Transfers and Validation Transfer of Analytical Methods, Qualification and Validation Program Assessments Facilities, Critical Utilities and Equipment Qualification Process Simulation Programs (Aseptic Processing Media Fills) Cleaning, Sanitization and Sterilization Processes
Project Planning/Management
Preclinical/clinical phases, Active Pharmaceutical Ingredient (API)/Drug Substance (DS)/Drug Product (DP)/placebo process development, Manufacturing of DS/DP, process validation, Supply chain management of biological investigational products for clinical trials, Quality control/quality assurance considerations, Global regulatory strategies |