QA Consulting Services
- Quality System Development
- QA Management Responsibilities
- SOP/Procedure Development and Review
- Batch Record Review and Approval
- Risk Management
- Change Control Program
- CAPA Development/Support
- Quality Manual Development
- Vendor/Supplier Qualification
- Validation Review
- IND/NDA Review
- CMC Review/Development
- TMF Review
- CTA Review
Auditing Services
- GMP Audits
- GCP Audits
- GDP Audits
- Contract Manufacturer Audits
- Quality Systems Evaluation
- Compliance Gap Assessments
- Mock Regulatory Audits
- Pre Approval Inspection Support
- API ICH Q7A Audits
- ISO 9001:2000 Audits
- Labelling/Packaging Audits
- Supplier Audits
- Surveillance Audits
- Validation Audits
- Design of Audit Programs