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Quality

Corporate Fact Sheet

At Bilcare GCS, our commitment to quality defines the path to project success. Our quality systems are designed to maintain compliance with a host of regulatory requirements, as well as various industry and international standards and guidelines as applicable.

Regulatory History - Bilcare GCS Americas

Establishment License (FDA) – No 483s

  • License 2531012
  • Last Inspection: January 2007

DEA Licensing - No Citations / Issues

  • DEA Manufacturer's License (I-V) RB0326923
  • DEA Distributor License (I-V) RB0326771
  • DEA Exporter License (I-V) RB0326810
  • DEA Importer License (IIIN, IV) RB0326822
  • DEA Analytical License (I-V) RB0326795
  • Last DEA Inspection: September 2009
Regulatory History - Bilcare GCS Europe   
  • MHRA Licensed Site Number 12225
  • MHRA Manufacturer’s and Importers Licence MIA/10284
  • Manufacturer’s Authorization (Investigational Medicinal Products)
    • MA (IMP) 10284
    • 5 named QP’s
  • Manufacturer’s License (Assembly Only) AO/10284/1
  • Manufacturers “Specials” License MS/10284/1
  • Wholesale Dealers License WL/10284/1
  • Wholesale Dealers (Import) License WI/10284/1
  • Home Office Controlled Drugs (Narcotics) Licence (Schedule 2 to 4) Ref: 014766
  • Last GMP IMP inspection: August 2010
  • Last GDP Inspection: September 2009
Regulatory History - Bilcare GCS Asia        
  • Controlled Substance License (Storage and Distribution)
  • Manufacturing License from State FDA
  • Storage & Distribution License from State FDA
  • NDPS I License from State FDA
  • Planned MHRA Inspection to Take Place Soon
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