Expertise
Quality & Compliance
- Quality Systems Implementation & Optimization
- Compliance Audits & Inspection Readiness
- Regulatory Compliance and Data Integrity
- Analytical Lifecycle Management
- Training & Continuous Improvement
QC and R&D Labs
- LIMS/Empower Implementation and Integration
- Method Validation and Transfer
- Lab equipment/application Validation
- Lab Data Integrity & Regulatory Compliance
Drug Development & Tech Transfer
- TT From Molecule to Market – Efficient, Compliant, and ScalablePreclinical and Clinical Drug Development
- CMC (Chemistry, Manufacturing & Controls) Development
- Tech Transfer – R&D to Manufacturing Sites
- Site Transfer & Global Manufacturing Scaling
- Analytical Method Development & Transfer
Computer System Validation (CSV)
- Ensuring Compliance, Data Integrity, and Operational ExcellenceFull CSV Lifecycle Services
- Risk-Based CSV Strategy Development
- GAMP 5 framework
- Automation systems (MES, LIMS, DeltaV, PLC/SCADA) Validation
- Data Integrity & 21 CFR Part 11 / Annex 11 Compliance
Regulatory Affairs
- Supporting Global Drug Registration & Compliance
- Regulatory Strategy & Intelligence
- eCTD, Dossier Compilation & Publishing
- EU Regulatory Affairs
- FDA Regulatory Affairs (USA)
- Middle East Regulatory Affair
- Lifecycle Management & Post-Approval
- Regulatory Consultancy & Local Representation