Our unique approach, breadth of experience and integrated strategy will deliver the results you need
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
Qaulity Systems:
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
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