Auk Technical Services LTD  (ATS) is an international medical device, pharmaceutical and nutraceutical consulting firm, headquartered in Beverly Hills, California. Our company was formed in 2004.  Our organization collaborates with top drug and medical device experts around the world, and can offer you confidential advisement and assistance with:

• Regulatory Affairs: 510(k)/PMA submissions, development of CMC sections for NDAs, promotional and labeling FDA compliance advice for medical devices and drugs, Panel participation in FDA regulatory reviews.

• Management of FDA Pre-Approval and Quality System inspections

• Corrective action and remediation plans for Warning Letters, FDA 483s

• Part 11 compliance assistance

• Regulatory strategic planning and risk management advice and planning

• Manufacturing Advisement: injection molding, extrusion, electronic Assembly, software production control, reagent & media batch production, cell culturing, monoclonal antibody diagnostic testing Rapid Assay, protein purification, sterility testing, aseptic filtration, sterile filling and terminal sterilization