Regulatory & Guidelines Training

Overview

Mediature GxP Solutions Pvt. Ltd. (MGS) provides regulatory and guidelines training for pharmaceutical, biopharmaceutical, API, medical-device, laboratory, CRO, and other regulated organizations.

Our training focuses on clear interpretation of regulatory expectations and their practical application in quality systems, manufacturing, validation, computerized systems, pharmacovigilance, and inspection readiness.

Key Training Areas

• US FDA Requirements
• EU GMP
• WHO GMP
• PIC/S
• Revised Schedule M
• ICH Guidelines
• MHRA / TGA / ANVISA Expectations
• 21 CFR Part 11
• EU Annex 11
• GAMP 5
• Data Integrity
• Qualification & Validation Requirements
• Pharmacovigilance Regulations
• Audit & Inspection Expectations

Training Formats

• On-site training
• Virtual training
• Guideline-specific sessions
• Regulatory workshops
• Department-specific training
• Refresher training
• Case studies
• Knowledge assessments

Why Choose MGS

• Practical regulatory interpretation
• Multi-regulatory perspective
• Role-based training
• Cross-functional expertise
• Compliance-focused learning

Who We Support

• Pharmaceutical manufacturers
• API manufacturers
• Biopharmaceutical organizations
• Medical-device companies
• Laboratories and CROs
• Quality and regulatory teams
• Engineering, validation, PV, and IT teams