gCompliance provides technical consulting to the Biotechnology and Pharmaceutical Industry globally.
gCompliance has expertise in the following areas:
- Audits to API and Drug Product sites(CMOs)
- CMO Selection and Management
- Set up and Maintenance of GMP Facilities and
Operations
- PAI readiness and Training
- Multiple Agency Inspection Readiness
- Multiple Agency Regulatory Submissions
- Quality Systems – Continuous Improvement to SOPs,
Change Control Process
- Quality Control – Investigations, Assessments and CAPA
- LIMS, Trackwise or other QC Systems Set up,
Maintenance
- Quality Operations and Systems Training
- Clinical Drug Supply Management
- Product Complaints
- GMP Supply chain practices