Elan Drug Technologies

Elan Drug Technologies’ manufacturing and development capabilities provide a range of client services, including:  


Manufacturing: 
Oral solid dosage forms in bulk or packaged form; controlled substance manufacture; gateway testing/release for EU markets; and labelling and packaging.





Engineering Services: 
Project process, equipment, facilities and utilities.


Laboratory Services:
Quality control, raw materials/stability, microbiology, Bio-analytical, 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 Drug Technologies include: 

• project and portfolio management:  Dedicated project management teams to support products through all stages of development and manufacture
• site support functions:  Information technology, finance and human resources.

Compliance:

In the period 2002 to December 2008, Elan Drug Technologies has undergone inspections from various regulatory authorities including:

• U.S. Food and Drug Administration – 8 Audits
• EMEA Inspection - 1 Audits
• Irish Medicines Board – 9 Audits
• U.S Drug Enforcement Administration – 4 Audits
• Environmental Protection Agency – 15 Audits
• Health and Safety Authorities – 23 Audits
• Multiple client and consultant audits – 95 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.