Online Engineering/Regulatory Compliance

Service Description

Are you searching for competitive resources with significant remarkable experience to successfully implement continuous improvement programs fast and with high effectiveness? Our team have a deep understanding of the scale up, validation and compliance requirements of manufacturing process within medical device, bio-pharmaceutical, pharmaceutical and construction industries. Our team can help you optimize and obtain the best of your manufacturing process, methods, quality systems, technology and construction management. The engineering, scale-up, validation and regulatory compliance group will support your organization in the following initiatives: Statistical Tolerance Analysis * Mechanical Invention * Functional Prototyping * Design Drawing Development * Design Specification * Design and Technology Transfer * Method Development and Validation * Process Development and Characterization Studies * Project or Program Management * Construction Management * Facility, Process, Product, Material, and Computer System Validation * Cleaning Validation * Validation Training * Product Knowledge Transfer * Quality System Development and Implementation * Gap Analysis * Risk Assessments * Mitigation Plan Development * Quality System Procedures * Batch Record Review * Periodic Reviews * Complaint Report and Investigations * Internal and External Audit * Supplier Quality Management* Preventive and Corrective Maintenance Development and Implementation* Engineering Design Management* Construction Management* Financial Management BOOK NOW!