GxP Audit – Quality, Compliance, GxP Excellence
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QUALITY • COMPLIANCE • GxP EXCELLENCE

Complete GxP Solutions for the Pharmaceutical Industry

Practical, reliable and customized support across GMP, Quality Management Systems, Regulatory Affairs, Pharmacovigilance, Consultancy and Technical Training.

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✓ Solution-oriented approach
✓ Experienced professionals
✓ Compliance-focused delivery
QUALITY MANAGEMENT SYSTEMS

Quality Systems Built to Pass Any Inspection

Robust QMS design, gap assessments, CAPA effectiveness and data integrity support that keeps you inspection-ready every day of the year.

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✓ Gap assessments & remediation
✓ Data integrity (ALCOA+)
✓ Audit-ready documentation
GLOBAL REGULATORY AFFAIRS

Regulatory Strategy for Faster Market Access

End-to-end regulatory support — from dossier compilation and eCTD submissions to lifecycle management across global markets.

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✓ eCTD submissions
✓ Global dossier compilation
✓ Lifecycle management
PHARMACOVIGILANCE

Drug Safety Support, Case to Signal

Comprehensive pharmacovigilance services covering case processing, signal detection, aggregate reporting and PSMF support tailored to your product portfolio.

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✓ Case processing & signal detection
✓ Aggregate safety reporting
✓ QPPV support
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WHO WE ARE

Your Partner for Quality, Compliance & Regulatory Excellence

Mediature GxP Solutions Private Limited provides professional regulatory, quality management and compliance services for pharmaceutical and healthcare organizations.

Our team combines industry knowledge with a practical, solution-oriented approach to help organizations strengthen quality systems, improve compliance, manage regulatory requirements and build sustainable operational excellence.

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Why Mediature GxP Solutions?

  • Customized solutions for your requirements
  • Qualified and experienced GxP professionals
  • Centralized project coordination
  • Focus on quality and regulatory compliance
  • Training and capability development
  • Practical and solution-focused approach
OUR SERVICES

Solutions Designed Around Your GxP Needs

From quality systems to regulatory strategy, we help pharmaceutical organizations navigate complex requirements with confidence.

01
CSV & Digitalization

21 CFR Part 11 Compliance

21 CFR Part 11

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02
Pharmacovigilance Services

Aggregate Reporting

Aggregate Reporting

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03
Product Development & Technology Transfer

Analytical Development Support

Analytical Development

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04
Regulatory Strategy & Intelligence

Artwork & Labelling Review

Regulatory and quality-focused review of product labelling and artwork to improve accuracy, consistency, and compliance with approved product information.

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05
Training & Capability Development

Audit Readiness & Auditor Development

Audit Readiness & Auditor Development

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06
Quality & Compliance

CAPA Management

Structured CAPA support to address root causes, prevent recurrence, and strengthen quality-system effectiveness.

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07
Quality & Compliance

Change Control

Structured change-control support to assess impact, manage risk, and maintain the validated and compliant state of GxP systems and processes.

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08
Commissioning, Qualification & Validation

Cleaning Validation

Cleaning Validation

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09
CSV & Digitalization

Cloud System Assessment

Cloud System Assessment

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WHAT WE DO

Our Core GxP Services

A closer look at the capabilities behind our GxP solutions — from validation and audits to training and drug safety.

CQV
Commissioning, Qualification & Validation

DQ / IQ / OQ / PQ · FAT / SAT · URS · Equipment & Utilities Qualification

CSV
Computer System Validation

GAMP 5 · 21 CFR 11 · Annex 11 · Data Integrity · Validation Life Cycle Management

GxP Assessment
Risk & Compliance Evaluation

Risk & Impact Assessment · QMS Gap Analysis · Regulatory Readiness Mapping

Audit Readiness & Management
Inspection Preparedness

End-to-end Audit Prep · CAPA Management · Unbiased Audit Reports · Mock Regulatory Inspections

GxP Training & Upskilling
Capability Building & Compliance

GMP / GLP / GDP · Auditor Training · SOP-based Learning · Customized Workshops

  • POSH Training with Certified Trainer
  • First Aid and HR Trainings
Pharmacovigilance
Drug Safety & Signal Detection

Adverse Event Monitoring · Signal Detection · PV System Setup · Safety Compliance

Industries

Industries We Serve

Multidisciplinary GxP expertise applied across the industries where quality and compliance matter most.

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HOW WE WORK

A Practical, Transparent & Solution-Focused Approach

01

Understand

We understand your business, quality objectives and regulatory challenges.

02

Assess

We identify gaps, risks and improvement opportunities using a structured approach.

03

Implement

We work with your team to develop practical solutions and build organizational capability.

04

Improve

We support continuous improvement, monitoring and sustainable compliance.

INSIGHTS

Knowledge That Supports Better Compliance

Stay informed about GMP, regulatory affairs, quality systems and pharmaceutical safety.

GMP
GMP

Understanding Modern GMP Expectations

Practical perspectives on quality controls, documentation and continuous improvement.

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QMS
QUALITY

Building an Effective Quality Management System

Key principles for improving quality processes, audits and regulatory readiness.

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PV
SAFETY

Pharmacovigilance & Patient Safety

Why robust safety monitoring and risk management matter throughout the product lifecycle.

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GET IN TOUCH

Let's Strengthen Your GxP & Compliance Strategy

Tell us about your requirement and our team will get in touch with you.

Phone
+91 93170 57630
Email
bd@mediaturegxp.com
Address

Phase 1, New Nalagarh, Distt. Solan, Himachal Pradesh 174101, India

    Our Network

    Trusted by Leading Pharmaceutical Companies

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    In Pictures

    Moments From the Field

    Facility floors, client sites and training rooms across India — the team behind our GxP audits, validations and workshops.

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    Ready to Discuss Your Requirement?

    Whether you need regulatory guidance, quality support, GMP expertise or technical training, our team is ready to discuss your requirement.

    Request an Audit Call +91 93170 57630