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 firm offers full regulatory support including turn-key pharmaceutical, medical device and nutraceutical compliance advice and services. We also offer manufacturing start-up advisement.

Auk Technical Services offers confidential advice 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, including mock FDA PAI, PMA, 21 CFR 210/211 and QS Regulation 21 CFR 820 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

For pharmaceutical manufacturers and developers, we can assist with:

• Preparation for Global Agency Meetings including development of proactive strategies for negotiating and resolving CMC Issues

• Preparation for FDA & EU agency inspections

• Global regulatory document preparation & maintenance EU & Canadian DMFs, INDs, NDAs, ANDAs, MAAs, NDSs, amendments and variations.

• Preparation and full publication of Submissions using both ICH paper and electronic Common Technical Document (CTD) formats

ATS BIO Laboratory Services