Our Services
What We Offer
Quality Audit Services (GxP)
We provide worldwide auditing for various industries and standards, offering services that meet specific client needs including internal audits, supplier audits, remote audits, gap analysis, training, and consulting.
GCP Audits & Monitoring
Project ManagementGCP AuditsClinical MonitoringBioanalytical Monitoring
Project Management
- CRO/Site Identification & Selection
- Budget & Timeline Tracking
- Study Design Support
- Study Documents Review
- Control Correspondence Management
- Feasibility Studies
- Audit Queries Resolution
- Study-Specific Management Plans
GCP Audits
- System & Facility Audit
- GAP Audit
- For Cause Investigation
- Site Qualification Audit
- Regulatory Compliance Audit
Clinical Monitoring
- Clinical phase study integrity
- Protocol adherence verification
- Measurement quality assurance
- Subject safety monitoring
- Valid data collection oversight
Bioanalytical Monitoring (RTBA)
- Method Development
- Interference & Inference Testing
- Method Validation
- Robustness Assessment
GMP Audits
GMP Qualification AuditsCompliance & Upgradation AuditsGMP Consulting
GMP Qualification Audits
- Quality & IT Systems Qualification
- Organizational & Management Responsibilities
- Document Processes per GMP
- Employee Training Verification
- Facilities & Equipment Audits
Compliance & Upgradation Audits
- Establishing GMP Management Systems
- Gap Analysis & Assessment
- Planning per International Guidelines
- Implementation & Documentation Guidance
- Executive Training Programs
GMP Consulting
- Pharma Plant Set-Up Consulting
- Sourcing (Raw/Packing/Finished)
- Regulatory (CTD/eCTD Dossier Compilation)
- Contract Manufacturing Advisory
GLP Audits
Qualification of GLP FacilitiesGAP AnalysisStudy Protocol/Report AuditsProcess/Data Audits
Qualification of GLP Facilities
- Pre-study site qualification
- Facility inspections & assessments
- GLP principles and SOPs review
- Data Integrity & Traceability checks
GAP Analysis (21 CFR Part 58)
- 21 CFR Part 58 compliance review
- SOP coverage assessment
- Lab personnel qualification verification
- Facility & equipment verification
Study Protocol / Report Audits
- Document completeness review
- Raw data verification
- Personnel training assessment
- Equipment calibration verification
- Sample tracking & QAU reviews
- Final report compliance check
Process / Data Audits
- Process analysis & optimization
- Risk-based facility maintenance
- Data integrity verification
QMS Consulting & Training
QMS ConsultingGxP Training
QMS Consulting
- Determine applicable regulations
- Create compliance plans
- Assess & improve quality management procedures
- Implementation of QMS frameworks
- Continuous compliance monitoring
Training Programs
- Good Manufacturing Practice (GMP)
- Good Distribution Practice (GDP)
- Good Laboratory Practice (GLP)
- Data Integrity Training
- Quality Management Systems (QMS)
- Auditor Qualification Training
Regulatory Affairs Services
Regulatory StrategyProduct RegistrationeCTD PublishingLifecycle Management
Regulatory Strategy & Registration
- Regulatory strategy and planning
- New product registrations and marketing authorizations
- Dossier compilation, review, and submission
- Regulatory query (RFI) response management
- Gap analysis and remediation
- Regulatory due diligence
- CMC (Chemistry, Manufacturing & Controls) advisory
- API and Drug Master File (DMF) support
eCTD Publishing & Submissions
- eCTD publishing and validation
- Global submission management (US FDA, EMA, MHRA, TGA)
- Legacy document conversion
- SPL publishing
- Electronic submission (e-Conversion)
- Submission tracking and lifecycle management
- Regulatory document management
Lifecycle Management
- Product lifecycle management
- Variations, renewals, and change control
- Country-specific regulatory support (regulated & ROW markets)
- Post-approval commitment management