Integrated Laboratory Services   Microbiological, Chemical, & Physical Testing
9342 Jeronimo Road Irvine, Ca 92618 (949) 454~4587 [email_address] www.ils-us.com    
    ILS is a full service Lab   providing responsive expertise in microbiological and chemical   testing.  Our Team will ...
History of  Integrated Laboratory   Services <ul><li>Division of Alliance Medical Products; a contract manufacturing facil...
Laboratory Support Services <ul><ul><li>Sterilization Validation Support </li></ul></ul><ul><li>  </li></ul><ul><ul><li>In...
Microbiology <ul><ul><li>  Experienced cGMP Testing Facility   </li></ul></ul><ul><li>  </li></ul><ul><ul><li>Many Years T...
  Laboratory Support Capability (Partial Listing of capability) <ul><li>Antimicrobial Effectiveness Testing~Pharmaceutical...
  Laborato ry Services Laboratory Facil ities   ( 10,000sq.ft) <ul><li>Clean Steam Autoclave </li></ul><ul><li>  </li></ul...
  ILS Basic Market Strategy <ul><ul><li>Clinical Stage Product Testing </li></ul></ul><ul><ul><li>Commerical Stage Manufac...
ILS Regulatory Status <ul><li>Drug </li></ul><ul><li>        Federal FDA Registered Drug Establishment  </li></ul><ul><li>...
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Ils Information

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Ils Information

  1. 1. Integrated Laboratory Services   Microbiological, Chemical, & Physical Testing
  2. 2. 9342 Jeronimo Road Irvine, Ca 92618 (949) 454~4587 [email_address] www.ils-us.com    
  3. 3.    ILS is a full service Lab providing responsive expertise in microbiological and chemical testing. Our Team will manage your projects making outsourcing easy.
  4. 4. History of Integrated Laboratory Services <ul><li>Division of Alliance Medical Products; a contract manufacturing facility. </li></ul><ul><li>  </li></ul><ul><li>Initially we operated as an in-house support laboratory for a Fortune 100 company and most recently as an independent lab serving a diverse clientele in the pharmaceutical and medical device industries. </li></ul><ul><li>  </li></ul><ul><li>Privately held. </li></ul><ul><li>  </li></ul><ul><li>Fifteen year history within existing facility. </li></ul><ul><li>  </li></ul><ul><li>Highly skilled and experienced laboratory staff. </li></ul>
  5. 5. Laboratory Support Services <ul><ul><li>Sterilization Validation Support </li></ul></ul><ul><li>  </li></ul><ul><ul><li>In Process and Finished Product Testing </li></ul></ul><ul><li>  </li></ul><ul><ul><li>Broad Range of Microbiological and Chemical Testing </li></ul></ul><ul><li>  </li></ul><ul><ul><li>Raw Material Testing </li></ul></ul><ul><li>  </li></ul><ul><ul><li>Method Development and Validation </li></ul></ul>
  6. 6. Microbiology <ul><ul><li>  Experienced cGMP Testing Facility   </li></ul></ul><ul><li>  </li></ul><ul><ul><li>Many Years Testing in Biotech, Medical and Pharmaceutical Industry   </li></ul></ul><ul><li>  </li></ul><ul><ul><li>All Testing Conforms to ISO 13485:2003/9001:2000 Standards   </li></ul></ul>
  7. 7.   Laboratory Support Capability (Partial Listing of capability) <ul><li>Antimicrobial Effectiveness Testing~Pharmaceutical Products </li></ul><ul><li>  </li></ul><ul><li>Bioburden </li></ul><ul><li>  </li></ul><ul><li>Cytoxcity </li></ul><ul><li>  </li></ul><ul><li>Endotoxin </li></ul><ul><li>  </li></ul><ul><li>Enviornmental Monitoring </li></ul><ul><li>Microbial Limits Testing </li></ul><ul><li>  </li></ul><ul><li>Sterility Testing </li></ul><ul><li>  </li></ul><ul><li>General Assays </li></ul><ul><li>  </li></ul><ul><li>Chromotographic Analysis </li></ul><ul><li>  </li></ul><ul><li>Moisture Determination </li></ul>
  8. 8.   Laborato ry Services Laboratory Facil ities ( 10,000sq.ft) <ul><li>Clean Steam Autoclave </li></ul><ul><li>  </li></ul><ul><li>HPLC's </li></ul><ul><li>  </li></ul><ul><li>GC's </li></ul><ul><li>  </li></ul><ul><li>UV-VIS </li></ul><ul><li>  </li></ul><ul><li>FTIR </li></ul><ul><li>  </li></ul><ul><li>Cell Culture Lab </li></ul>
  9. 9.   ILS Basic Market Strategy <ul><ul><li>Clinical Stage Product Testing </li></ul></ul><ul><ul><li>Commerical Stage Manufacturing Stage Testing </li></ul></ul><ul><ul><li>Overflow Alternative for In-House Testing </li></ul></ul><ul><ul><li>2nd Source Verification Testing </li></ul></ul><ul><ul><li>Specialty Product Testing Not Available at In-House Lab </li></ul></ul><ul><ul><li>Customer Base Ranges from Fortune 500 to Small Start Up in the Biotech, Pharmaceutical, and Medical Device Industries </li></ul></ul>
  10. 10. ILS Regulatory Status <ul><li>Drug </li></ul><ul><li>       Federal FDA Registered Drug Establishment </li></ul><ul><li>     California State Food and Drug Branch Licensed   </li></ul><ul><li>        Drug Manufacturing Facility   </li></ul><ul><li>  </li></ul><ul><li>Device </li></ul><ul><li>    Federal FDA Registered Device Establishment </li></ul><ul><li>      California State Food and Drug Branch Licensed Device   </li></ul><ul><li>     Manufacturing Facility </li></ul><ul><li>  </li></ul><ul><li>ISO  </li></ul><ul><li>       ISO 9001-2000, ISO 13485-2003, EN 46001 Certified </li></ul>

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