Our team of Consultants at Vastek Inc. are experienced in Product Development, Quality, Manufacturing, Validation, Regulatory etc. guides companies through all aspects of U.S and EU regulatory compliance challenges. Our team has the expertise on regulations of various products, including food, drugs, devices and biologic products; through the entire product life cycle.
Quality / Manufacturing / Validation
Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications.
Vastek provides consulting services in the following areas.
– Design and Development (Planning, Input, Output, Review, Verification, Validation, Transfer)
– Risk Management
– Usability Engineering
– Product Software
– Device Labeling
– Validation of Processes for Production and Service Provision
– Identification and Tractability
– Quality Audits