FDA & ISO Mock Auditing and Inspections
Compliance Assistance Services

Surviving FDA inspections is critical to your success.  ATS can:

  • Prepare personnel for an FDA or ISO audit
  • Evaluate a facility and recommend improvements
  • Perform a “mock audit” or “mock inspection” and a subsequent debriefing
Medical Software and Firmware Development
Design, Development and Testing Services

ATS’s software expertise can assist you in all software aspects of medical device development.  Capabilities include:

  • Performing software audits to FDA Requirements
  • Product development assistance and software/hardware design choices
  • Product software & firmware development
  • Software testing
Your Road Map to 510(K) Success.

The FDA “Premarket Notification”, or “510(k)” must be filed with the FDA before marketing a medical device.   Familiarity with the 501(k) submission process can save the device manufacturer considerable time and money.  Key issues involve proper device classification and predicate selection, and careful background research into similar products and their histories.

ATS’s ex-FDA staff, scientists and engineers are completely familiar with the 510(k) submittal process, and have successfully assisted many clients in their 510(k) approval processes.

Home of the Industry’s Top Regulatory Compliance Experts

Auk Technical Services Employs Only the Finest FDA Consultants to Guide You to Compliance. Leverage Our Ex-FDA Staffers & Investigators Now!

Contact ATS Now to Achieve Total FDA Compliance

 ATS offers many services, including:

Capital Equipment Buildout

ATS helps select the Contract Manufacturer:

  • Granting access to our AUK ATS BIO in house manufacturing capability
  • Granting access to our fully ISO 13485:2003, FDA registered, California licensed electrical manufacturing arm
  • Audit contract manufacturing sites specially modeled after client needs
  • ATS can also assist in bringing current client suppliers up to FDA quality expectations

Process Validation

Process validation/quality engineering experience, and helping create or correct IQ OQ PQ studies on:

  • 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

Pharmaceutical Product Advisement Services

ATS has staff and experience to help the client 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
  • Laboratory Services

Contact our FDA Consultants today; Leverage Our Ex-FDA Staffers & Investigators Now!