GMP Consultation Services
Expert GMP consultancy to help pharmaceutical manufacturers achieve and maintain global regulatory compliance.
GMP Gap Assessment
A complete evaluation of your facility, systems, and documentation against applicable regulatory standards.
Standards Covered
- Schedule M (India)
- WHO GMP
- PIC/S GMP
- UK MHRA GMP
- EU GMP
- US FDA 21 CFR Parts 210 & 211
- ICH Guidelines
- Data Integrity Guidelines
Assessment Scope
- Facility design and layout review
- HVAC systems
- Water systems (PW/WFI)
- Compressed air and gases
- Environmental monitoring
- Production operations
- Warehouse and material handling
- QC and Microbiology laboratories
- Documentation systems
- Validation systems
- Qualification systems
- Quality Management System (QMS)
- Deviation, CAPA, Change Control
- Vendor qualification
- Self-inspection program
What You Receive
- Detailed gap analysis report
- Risk-based remediation plan
- Compliance roadmap
- CAPA recommendations
- Inspection readiness strategy
Ready for a Gap Assessment?
Identify compliance gaps before regulators do. Get a comprehensive roadmap.
Request AssessmentRegulatory Audit Readiness
Comprehensive preparation for inspections by global regulatory authorities — so you walk in confident.
Preparation for Inspections by:
Mock Audits
Simulated inspections replicating real regulatory audits — conducted by experienced ex-regulatory personnel to expose gaps before the actual inspection.
Documentation Review
- SOPs
- BMR/BPR
- Validation documents
- Qualification reports
- Logbooks
- Specifications
- STPs
- Calibration records
- Investigation reports
- Training records
- APR/PQR
- Site Master File
- Quality Manual
Shop Floor Readiness
- Operator GMP behavior
- Gowning practices
- Line clearance
- Documentation practices
- Data integrity compliance
- Housekeeping standards
Interview Preparation
Targeted training for every department to ensure confident, accurate responses during regulatory interviews.
Training covers:
- QA team
- QC team
- Production team
- Engineering
- Warehouse
- Microbiology
- Regulatory affairs
- Top management
Current GMP (cGMP) Training
Practical and regulatory training on the latest GMP expectations — designed for pharmaceutical manufacturing teams.
A. Schedule M GMP Training
- New revised Schedule M requirements
- Pharmaceutical Quality System
- Risk Management
- Documentation practices
- Personnel qualification
- Facility requirements
- Validation expectations
- Data Integrity
B. WHO GMP Training
- WHO GMP guidelines overview
- Quality systems and documentation
- Manufacturing controls
- Laboratory controls
- Inspection preparation
C. Data Integrity Training
- ALCOA+ principles
- Paper-based systems
- Computerised systems (GAMP5)
- Audit trails
- Regulatory expectations
Why NGT for GMP Consultations?
Backed by 30+ years of pharmaceutical infrastructure expertise and 300+ regulatory audits supported globally.
Experienced Consultants
Our team holds decades of hands-on experience with USFDA, MHRA, WHO and TGA inspections across regulated markets.
End-to-End Support
From initial gap assessment through audit preparation, training and post-inspection CAPA — we support the complete compliance journey.
Proven Track Record
300+ regulatory inspections successfully supported across India and internationally for leading pharmaceutical companies.
Ready to Strengthen Your GMP Compliance?
Contact our GMP experts today. We'll assess your current compliance status and design a tailored roadmap to regulatory success.