Qualified Person (QP) Support Services
ISHA’S GMP Turnkey Consultancy Europe Ltd provides experienced Qualified Person (QP) services to support pharmaceutical manufacturers operating under EU GMP and Manufacturing Import Authorisation (MIA) licence requirements.
Our QP professionals provide independent quality oversight, batch certification, compliance review, and regulatory support for pharmaceutical operations across Europe.
Our Approach:
To ensure effective QP oversight, our professionals undergo detailed training on:
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Product knowledge
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Manufacturing processes
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Quality systems
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Supply chain operations
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Batch release procedures
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Regulatory expectations
Support can be provided onsite or remotely depending on client and regulatory requirements.
Commitment:
We deliver QP services with a strong focus on:
Patient safety
Regulatory compliance
Product quality
Data integrity
Professional integrity
Operational excellence
Why Choose ISHA'S GMP Turnkey Consultancy Europe Ltd?
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Global GMP Expertise
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End-to-End Turnkey Solutions
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EU GMP & International Regulatory Knowledge
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Experienced Multidisciplinary Team
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Practical & Cost-Effective Engineering
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Strong Quality & Compliance Focus
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Flexible Client-Centric Approach
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Reliable Project Execution Support
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Future-Ready Pharmaceutical Solutions
We are committed to helping pharmaceutical and life sciences organizations achieve operational excellence, regulatory compliance, and sustainable business growth through reliable engineering, consultancy, and turnkey project solutions.
QP, RP & Regulatory Support Services
Qualified Person (QP) & Responsible Person (RP) Services
ISHA’S GMP Turnkey Consultancy Europe Ltd provides comprehensive QP, RP, regulatory compliance, batch release, and quality assurance support services for pharmaceutical, biotechnology, API, and healthcare companies operating within Europe and global markets.
Our experienced professionals support manufacturers, importers, distributors, and virtual pharmaceutical companies in maintaining full compliance with EU GMP, GDP, MHRA, and European regulatory requirements.
Contract QP Services
RP Services
Product Launch Services (In Europe)
Batch Certification & Batch Release
EU GMP Compliance Support
MIA Licence Support
Supply Chain GMP Oversight
Quality System Evaluation
Deviation, CAPA & Change Control Review
Regulatory Inspection Readiness
GMP Audit Support
Technical Quality Consultancy
Product Quality Review (PQR) Services
Stability Data Review
API Declaration Services
We provide experienced Qualified Person (QP) services to support pharmaceutical companies operating under Manufacturing Import Authorisation (MIA) requirements within Europe.
Our QP professionals ensure that medicinal products are manufactured, tested, released, and distributed in compliance with EU GMP regulations and marketing authorisation requirements
Our Contract QP Services Include:
- Remote & Onsite QP Support
- Batch Certification & Release
- Quality System Oversight
- GMP Compliance Review
- Manufacturing & Packaging Record Review
- Deviation & CAPA Assessment
- Supplier & Supply Chain Compliance Review
- Audit & Inspection Support
- Product Quality Review
- Technical Quality Oversight
Benefits:
- Regulatory-compliant batch release
- Reduced compliance risk
- Independent quality oversight
- Flexible QP support solutions
- Enhanced inspection readiness
We provide Responsible Person (RP) services for pharmaceutical wholesalers and distributors operating under EU GDP regulations.
Our RP professionals ensure compliance with Good Distribution Practice (GDP) requirements for the storage, transportation, and distribution of medicinal products across Europe.
RP Services Include:
- RP Appointment Support
- GDP Compliance Oversight
- Wholesale Distribution Authorisation (WDA) Support
- GDP Gap Analysis
- Supply Chain Quality Management
- Vendor Qualification Support
- Temperature Excursion Management
- Complaint & Recall Management
- Self-Inspection & Audit Support
- GDP Training & Documentation
Key Advantages:
- Full GDP compliance support
- Improved supply chain integrity
- Enhanced patient safety
- Regulatory inspection preparedness
- Effective quality management systems
Product Launch Support Includes:
- EU Market Entry Support
- Regulatory Coordination
- Batch Release Management
- Supply Chain Readiness
- Artwork & Packaging Compliance Review
- Product Transfer Coordination
- Third-Party Manufacturing Oversight
- Stability & Quality Documentation Review
- Distribution & Logistics Compliance
- Launch Risk Assessment
Benefits:
- Faster market entry
- Reduced launch delays
- Improved regulatory coordination
- Smooth commercialisation process
- Strong quality oversight
Our QP professionals provide independent batch certification and release services in accordance with EU GMP requirements.
We ensure that each medicinal product batch has been manufactured and tested in compliance with regulatory requirements and approved specifications.
Services Include:
- Batch Record Review
- Analytical Data Verification
- Deviation & CAPA Assessment
- Change Control Evaluation
- Supplier Qualification Verification
- Product Release Certification
- Importation Compliance Review
- QP Declaration Support
Advantages:
- Compliant product release
- Improved product quality assurance
- Reduced regulatory risk
- Reliable batch disposition decisions
We help pharmaceutical organizations establish, maintain, and improve compliance with European GMP regulations and international quality standards.
Compliance Support Includes:
- EU GMP Gap Analysis
- GMP System Implementation
- Quality Risk Management
- SOP Development
- Data Integrity Compliance
- GMP Training Programs
- Inspection Preparation
- Mock Regulatory Audits
- Technical Compliance Advisory
Benefits:
- Stronger GMP systems
- Improved inspection readiness
- Reduced compliance gaps
- Sustainable quality culture
We provide expert consultancy for obtaining and maintaining Manufacturing Import Authorisation (MIA) licences within Europe.
Services Include:
- MIA Application Support
- Regulatory Documentation Preparation
- Facility Compliance Review
- GMP Readiness Assessment
- QMS Development
- Regulatory Authority Coordination
- Inspection Preparation & Support
Key Benefits:
- Streamlined licensing process
- Faster regulatory approvals
- Improved compliance readiness
- Reduced regulatory risks
We support pharmaceutical companies in maintaining GMP compliance throughout the entire supply chain.
Services Include:
- Supplier Qualification & Audits
- Contract Manufacturer Oversight
- Distribution Compliance Review
- Transportation Risk Assessment
- Supply Chain Quality Monitoring
- Cold Chain Compliance Support
- Vendor Performance Evaluation
Advantages:
- Improved product integrity
- Enhanced supply chain visibility
- Reduced compliance risks
- Better vendor management
We perform detailed evaluations of pharmaceutical quality systems to identify compliance gaps and improvement opportunities.
Evaluation Scope:
- Quality Management System (QMS)
- Documentation Systems
- Training Systems
- CAPA Management
- Change Control Systems
- Deviation Management
- Complaint Handling
- Audit Programs
- Data Integrity Compliance
Benefits:
- Improved system effectiveness
- Stronger compliance controls
- Better operational efficiency
- Continuous quality improvement
We provide independent technical and quality review of deviations, CAPAs, and change controls to ensure regulatory compliance and effective risk management.
Services Include:
- Root Cause Investigation Support
- CAPA Effectiveness Review
- Change Impact Assessment
- Risk-Based Evaluation
- Quality Documentation Review
- Trending & Compliance Monitoring
Benefits:
- Stronger quality oversight
- Reduced recurrence of issues
- Improved compliance management
- Better risk mitigation
We help organizations prepare for inspections by regulatory authorities including MHRA, EMA, EU authorities, and international agencies.
Inspection Readiness Services:
- Mock GMP Inspections
- Documentation Review
- Audit Preparation
- Facility Readiness Assessment
- Inspection Response Support
- Personnel Training & Coaching
- CAPA Support Following Inspections
Benefits:
- Increased inspection confidence
- Reduced inspection observations
- Improved staff preparedness
- Faster regulatory response
Our experienced auditors perform comprehensive GMP and GDP audits across pharmaceutical manufacturing, distribution, and supply chain operations.
Audit Services Include:
- Internal GMP Audits
- Supplier & Vendor Audits
- Contract Manufacturer Audits
- GDP Audits
- Third-Party Compliance Audits
- Audit Report Preparation
- CAPA Follow-Up & Closure
Advantages:
- Improved compliance monitoring
- Better supplier control
- Enhanced quality assurance
- Risk reduction across operations
We provide strategic technical and quality consultancy to support pharmaceutical manufacturing, compliance, and operational excellence.
Consultancy Areas:
- GMP Compliance Strategy
- Pharmaceutical Quality Systems
- Process Improvement
- Risk Management
- Regulatory Advisory
- Quality Metrics & KPI Development
- Operational Excellence Programs
Benefits:
- Improved manufacturing quality
- Enhanced operational efficiency
- Stronger regulatory compliance
- Long-term quality improvement
We support pharmaceutical companies in preparing and reviewing annual Product Quality Reviews (PQRs) in accordance with EU GMP requirements.
PQR Services Include:
- Product Trend Analysis
- Batch Data Evaluation
- Deviation & OOS Review
- Stability Trend Review
- CAPA Effectiveness Assessment
- Process Consistency Evaluation
- PQR Report Preparation
Benefits:
- Improved product lifecycle management
- Enhanced process monitoring
- Regulatory compliance assurance
- Better quality trend visibility
We provide scientific review and assessment of pharmaceutical stability data to support regulatory submissions and ongoing product quality monitoring.
Services Include:
- Stability Trend Analysis
- Data Review & Interpretation
- Shelf-Life Evaluation
- OOS & OOT Assessment
- Stability Protocol Review
- Regulatory Documentation Support
Advantages:
- Improved product quality assurance
- Stronger regulatory support
- Reliable shelf-life evaluation
- Better stability management
We provide API Declaration support services to help pharmaceutical companies comply with European regulatory requirements for active pharmaceutical ingredients (APIs).
Services Include:
- API Compliance Assessment
- Written Confirmation Support
- Supplier GMP Evaluation
- API Documentation Review
- Regulatory Submission Support
- Third-Party API Compliance Coordination
Benefits:
- Improved API compliance
- Reduced regulatory risk
- Stronger supplier qualification
- Enhanced supply chain assurance
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