Expertise

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Quality & Compliance

Quality Systems Implementation & Optimization
Compliance Audits & Inspection Readiness
Regulatory Compliance and Data Integrity
Analytical Lifecycle Management
Training & Continuous Improvement

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QC and R&D Labs

LIMS/Empower Implementation and Integration
Method Validation and Transfer
Lab equipment/application Validation
Lab Data Integrity & Regulatory Compliance

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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

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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

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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