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
