Design Qualification
- Review design of facility,
equipment and system to make sure it meet both regulatory requirements,
industry standards and your needs
Qualification & Validation
- Guide you through equipment qualification,
utility qualification, method validation, process validation, cleaning
validation
SOP Compliance
- Compliance with regulatory
requirements and inspection trends, consistency of “SOP-Operation-Record"
Quality Activities
- Deviation handling, change control, supplier qualification,
risk management, etc.
Training
- Project based training for
your quality management people and technical / operation supervisors
Submission
- Prepare and review ANDA, DMF, VMF
- Answer deficiency letters
Inspection
- Handle inspection from
regulated market authorities
- Respond to inspection observations, including Warning Letters
Audit
- Audit manufacturing facilities based on your acceptance criteria