Elan's manufacturing and development capabilities provide a range of client services, including:  

Manufacturing:  Oral solid dosage forms in bulk or packaged form; controlled substance manufacture in the United States; gateway testing/release; and labeling and packaging.
Engineering Services:  Project process, equipment, facilities and utilities.
Laboratory Services: Quality control, raw materials/stability, validation and compliance.
Development Capability:  Formulation, analytical development, scale-up and process transfer.
Regulatory:  Regulatory dossier preparation, submission and support.

Professional management services at Elan include: 

  • Project and Portfolio Management:  Dedicated project management teams to support products through all stages of development and manufacture
  • Global Supply Chain Management:  Strategic sourcing, demand planning, package design and control, and contract product procurement
  • Site Support Functions:  Information technology, finance and human resources.                 

Compliance

In the period 2002 to July 2007, Elan has undergone successful inspections from various regulatory authorities including:

  • U.S. Food and Drug Administration
  • Irish Medicines Board
  • U.S Drug Enforcement Administration
  • Environmental Protection Agency
  • Health and Safety Authorities
  • Multiple client and consultant audits                     

Environmental Control and Safety

Environmental

  • Dedicated department for management, monitoring and reporting
  • Integrated pollution control license
  • Facilities in place for waste water, air emissions (particulates, VOC’s), noise control, hazardous waste liquids & solids, surface water retention.                     

Safety

  • Dedicated safety management team
  • Full safety management system including, self- inspection, near miss incident reporting and trending, safety meetings and routine health screening on site.                     

Best-in-Class Systems

Elan's dedication to best-in-class systems underlies its commitment to providing the highest quality service to our clients.

  • Enterprise System
    • SAP                     
  • Networks
    • NT4
    • Oracle database
    • Intranet/extranet                     
  • Laboratory Systems
    • LIMS
    • Chromatographic network system - Millennium
    • Dissolution network system - IDIS                     
  • Maintenance Management
    • Permac                     
  • SCADA
    • Supervisory Control and Data Acquisition (of processing Group)
    • Current and throughout facility                     
  • Automated Warehouse and Dispensary                     

Packaging

  • Vial labelling and cartoning
  • Blister
  • Bottle                     
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