Please contact us to assist with your compliance and quality goals.
Coda Corp USA's team of knowledgeable Quality Engineers, Validation Consultants, and Certified Auditors are ready to assist you with your needs. Contact us today for a free estimate!
Coda Corp USA
PO Box 826
Fairport, NY 14450
866.872.2070
Outside US:
866.872.2072
info@codacorpusa.com See our Services for a comprehensive list of services, which include:
- FDA based Quality Assurance - Quality System evaluation, development and management, Training, SOP design, and preparation, planning, conducting, and hosting audits, training auditors and training for those being audited
- Validation - Process (Liquid and Solid Manufacturing and Packaging, Medical Device, Facility and Utility including Sterile Buildings), Equipment, Enterprise and local Automation (LIMS, MRP, MES, ERP, SCADA, PLC, CDS, Laboratory Interfaces, Climatic Controls)
- Regulatory Compliance - 510ks, BLAs, NDAs/ANDAs, SUPAC communications, Remedial Action plans (preparation, management, and execution), 483s, Warning Letter Response and remedial planning, Consent Decree management, APRs/MDRs (preparation and review), hosting agency audits, recalls, rework and adverse event reporting
- Project Management - project and personnel, including staffs of permanent and contract employees, senior resource mentoring and junior resource development