Services & Products, Valtech LLC

Project Achievements for Clients

• Resolved FDA compliance issues for GxP’s.
• Prepared responses to FDA 483’s and Warning Letters.
• Prepared regulatory impact analysis for Wall Street firms including assessments for M&A’s and financial impact with FDA’ regulatory action.
• Regularly assists company management in developing compliance audit programs, executing audits, assessing results and implementing timely and effective corrective and preventive actions.
• Competent auditing to ISO/IEC 14385 for competency of medical device manufacturing and ISO/IEC 15189 for medical device testing.
• Supply chain strategies bulk, components and sterile finished products involving RFID, dental, In-vitro diagnostic devices
• Performed and provided guidance for due diligence assessments involving the acquisitions of pharmaceutical, medical device, and food processors facilities.
• Performed numerous gap analysis on the adequacy of Quality Management Systems, and deviational systems for 21 CFR Parts 58, 110-111, 210-211, 225, 510, 803, 806, 807, 820, (PHS Act) 1271 and CGTP requirements.
• Provided IQ, OQ, PQ requirements/traceability, evaluated assessments, revised protocols and procedures, prepared reports for establishing criteria for Change Management.
• Evaluated numerous manufacturing records and device file records for compliance, quality, and efficiency improvement for sterile and non-sterile products.
• Performed numerous audits of computer system 21 CFR Part 11 system compliance gap assessments and reporting.
• Experience with aseptic, steam, ETO, and gamma radiation sterilization treatments used in food, biopharmaceutical and medical device manufacturing.
• Provided numerous audit for Class 1, 2, and 3 Medical devices and Biological combination
• Develop, prepare, validate, and evaluate the adequacy of CAPA’s and provide effective metrics for root cause. Including discerning determination MDR reporting reorting.
• Prepare facilities, provide training and perform simulated FDA mock audits for drugs, biologics, medical devices using human tissue and GLP.
• Importation assistance for FDA regulated products.
• Provide Establishment Registration and listing service for dietary supplements, OTC Drugs and medical devices.
• US Agent for pharmaceuticals and foods imports.
• Reviewed conformity of human tissue based products for implant and combination biologic/devices.
• Sterility processes pharmaceuticals, medical devices and biologics
• Craft labeling for foods, dietary supplements, OTC drugs, medical devices and cosmetics.