Where ALKU Can Help

From remediation projects to new facilities or quality system improvements, ALKU can assume complete responsibility or simply act in an advisory capacity.

 

Quality

  • Manufacturing
  • Risk Management
  • Process
  • SOP Creation/Revision
  • Design
  • CAPA
  • Supplier
  • SCAR
  • Investigators
  • Complaints

 

Validation

  • Process
  • Utilities
  • Cleaning
  • Sterilization
  • Software
  • Method
  • Computer Systems
  • Equipment
  • Facilities
  • Instrumentation

 

Project Management

  • Program Managers
  • Technology Transfer PM
  • Remediation PM
  • UDI PM

 

Regulatory Affairs

  • Submissions
  • Supplements
  • Strategy
  • International Submissions
  • Labeling
  • International Strategy

 

ALKU in the press

MostPromising2015
Inc 500
SIA Fastest Growing 2015