Strengthening
your pharmaceutical 
operations with
proven QP leadership
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QP / RP Services
At QP Pro Services, our Qualified Persons (QP) and Responsible Persons (RP) are certified industrial pharmacists who provide comprehensive oversight of regulatory compliance. Our team ensures the highest standards in product release, GMP, batch certification, and ongoing operational performance, leveraging real-world expertise in the pharmaceutical industry.
The unique selling points and
advantage of our feature.
Batch Certification & Release
(EU Annex 16)
- Full compliance with EU Annex 16 for batch release and certification, ensuring all medicinal products meet regulatory safety standards before they are released into the market.
- Our QP experts provide batch certification for commercial and investigational medicinal products, handling all the necessary compliance checks to ensure product safety and regulatory adherence.
AFMPS / EMA Representative
& Regulatory Liaison
- Acting as your direct liaison with regulatory authorities, including the AFMPS (Federal Agency for Medicines and Health Products) and EMA (European Medicines Agency).
- We manage all interactions with regulatory bodies to ensure timely updates and seamless communication on regulatory issues, submissions, and compliance.
GMP Oversight
& Regulatory Compliance
- Providing full GMP oversight across manufacturing, quality control (QC), MS&T (Manufacturing Science and Technology), and the supply chain.
- Our QPs ensure that your operations maintain compliance with EU GMP, FDA, and PIC/S standards, providing ongoing support for inspection readiness and GMP performance.
GDP Guidance & Compliance
for Wholesale Distribution
- Expert guidance on Good Distribution Practices (GDP) for the safe and compliant distribution of pharmaceutical products.
- Ensuring that your storage, transport, and distribution practices meet the required standards for temperature-sensitive and controlled substances.
Temperature-Controlled Storage
& Distribution Compliance
- Oversight of temperature-controlled storage for products stored at 2–8°C, −20°C, −70°C, and ultra-cold conditions.
- Full responsibility for maintaining product quality through the distribution process, with transport oversight and risk assessments of transport lanes.
Full Product Lifecycle Responsibility
- Providing end-to-end product responsibility, from the point of entry into the EU market through batch release and up to product distribution.
- Ensuring full compliance with all GMP and GDP standards for the complete lifecycle of your product.
Why Choose QP Pro Services
for QP / RP ?
From batch certification to contamination control, our QPs provide end-to-end support across all stages of the product lifecycle.
We understand the intricacies of pharmaceutical operations and regulatory frameworks, ensuring your business remains compliant and operationally efficient.
Our QPs work directly with your teams, providing seamless integration and hands-on support, allowing for quick problem-solving and effective operational strategies.
Your Operational Support for your Pharmaceutical compliance.
Contact Us- Trusted success
- Professional Guidance
Hands-On Support
We work close to your teams, helping them implement, document and sustain compliant practices on the shop floor.
Risk-Based Approach
We focus on what really matters for product quality and patient safety, prioritising actions based on a structured risk assessment.
Clear Documentation
We help you design, simplify and maintain documentation that is audit-ready and easy for your teams to use every day.
Qualification & Validation
Full qualification and validation services for manufacturing processes, equipment, cleaning, and systems (CSV).
Ensuring compliance with EU GMP and global standards through robust validation protocols (IQ, OQ, PQ).
Environmental Monitoring & Control
-
Ongoing environmental monitoring to ensure that your production environment remains compliant with the required GMP standards for controlled environments
(e.g., cleanrooms). - We handle monitoring of key parameters like temperature, humidity, particulate contamination, and air quality.
Service we’re
always provide
Contamination Control Strategy (CCS)
- Design and implementation of Contamination Control Strategies to minimize contamination risks across all production areas.
- We ensure that your contamination control practices meet regulatory expectations, ensuring a sterile and safe environment for pharmaceutical manufacturing.
Visual Inspection & Quality Control
- Providing visual inspection services for products, ensuring all packaging, labeling, and product integrity meet regulatory and company standards.
- Quality control (QC) oversight for product testing, stability studies, and release testing, ensuring each batch is safe for distribution.
Monitoring & Process Optimization
- Monitoring of production processes to ensure continuous compliance with GMP and to identify areas for optimization.
- Our team helps in the optimization of workflows, reducing inefficiencies, improving production timelines, and enhancing overall product quality.
Computer System Validation (CSV)
- Ensuring that all critical systems (including IT systems, laboratory equipment, and manufacturing processes) are qualified and validated to meet regulatory standards.
- Expertise in Computer System Validation (CSV) for both hardware and software, ensuring data integrity and compliance with regulatory guidelines.
Support for Audits & Inspections
- Assistance with preparing your organization for internal and external audits, ensuring all documents and systems are inspection-ready.
- Our team provides comprehensive support for audit preparation and ensures that your operations pass with minimal observations or findings.
Deviation Management & CAPA
- We assist in deviation management, ensuring timely and effective resolution of deviations and ensuring that corrective actions are properly implemented through CAPA (Corrective and Preventive Action) plans.
- Managing the entire CAPA process to ensure continuous improvement in manufacturing practices.
SOP Development & Process Improvement
- SOP development for critical operational processes, ensuring standardization and compliance across your business.
- Process improvement strategies to enhance efficiency, reduce costs, and maintain high-quality production standards.
We optimize operations
Enhancing qualification, aseptic performance, and MS&T activities.
We analyze & anticipate
Using monitoring, data trends, and process intelligence to drive decisions.
We secure performance
Ensuring reliability, compliance, and flawless execution every day.
Drug Product EU Importation.
We secure compliant, efficient, and reliable importation routes for medicinal products entering the European market.
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What we provide for our EU Importation service.
- Full compliance with the Manufacturing and Importation Authorisation (MIA) framework.
- Assessment of your importation route to ensure alignment with EU directives and national competent authority expectations.
- Ensuring all importation processes meet EudraLex Volume 4 and GDP/GMP requirements.
- Comprehensive risk analyses for products, routes, partners, and distribution conditions.
- Gap analysis of existing systems to identify missing requirements for EU importation.
- Definition of corrective actions to reach full compliance and inspection readiness.
- Preparation, submission, and follow-up of regulatory dossiers, including variations and renewals.
- Ensuring alignment with EMA, CMDh, and national authority requirements.
- Support through regulatory lifecycle management to maintain compliant market presence.
- Ensuring your imported products meet EU pharmacovigilance requirements (PSMF, signal detection, ICSRs, periodic reports).
- Regulatory intelligence and vigilance to track evolving EMA and national authority expectations.
- Oversight of safety communication, quality defects, and recall strategy interactions.
- Guidance on strategies to enter or expand on the EU market.
- Alignment of regulatory pathways, dossier structure, and quality documentation.
- Support for interactions with EMA, AFMPS, and other competent authorities.
- Verification that suppliers, transporters, and warehouses meet GDP/GMP requirements before QP certification ever occurs.
- Review of CoA, CoC, temperature data, transport deviations, storage conditions, and supply chain documentation.
- Importation documentation compilation required for QP certification (non-QP decision making).
- Ensuring full oversight of 2–8°C, −20°C, −70°C and ultra-cold chain importation conditions.
- Review and approval of transport lanes, qualification of partners, and oversight of deviations related to import activities.
- Implementation of quality agreements with third-country manufacturers and distributors.
- Coordination with customs, freight forwarders, and importation pathways.
- Ensuring documentation completeness (shipping documents, proforma invoices, import certificates).
- Follow-up until the batch is fully eligible for QP certification.
End-to-End EU Import Compliance
We ensure full regulatory adherence under the MIA framework, managing every step from EU entry to final QP certification.
Risk & Quality Excellence
Comprehensive quality, documentation, and risk assessments to guarantee GMP/GDP alignment before market release.
Accelerated Market Access
Fast, secure coordination with authorities (EMA, AFMPS) and efficient management of dossiers, variations, and vigilance activities.
Hundreds of batches imported and certified annually
Trusted by global manufacturers and MAHs worldwide
Over 20 years of combined QP import expertise
Fully integrated with your QA, RA, and Supply Chain systems
Inspection Readiness service.
Assessment
Initial gap assessment, risk review, and readiness scoring to identify vulnerabilities before inspectors do.
Preparation
Document organization, evidence mapping, mock inspections, and staff training to build inspection confidence.
Execution
On-site coaching, SME alignment, document control flow, and real-time support during inspection days.
Response & Improvement
CAPA strategy, observation/483 responses, regulatory alignment, and system strengthening for future inspections.
Service we provide your business
corporate consulting.
Pre-Inspection Assessment & Audit (Gap & Risk Review)
Full audit-style review of your QMS, operations, documentation, and data integrity practices to identify gaps before inspectors do.
Includes document organization, evidence mapping, and verification of GMP/GCP/GDP compliance.
Mock Inspections (EU GMP, GDP, FDA, PIC/S)
Realistic mock audits led by senior QPs/QA experts to surface vulnerabilities, test your teams under inspection pressure, and simulate real regulatory scenarios.
Documentation, Data Integrity & Audit Trail Review
Verification that batch records, QC data, deviations, CAPAs, change controls, audit trails, and traceability meet inspector expectations.
Clear mapping of evidence so inspectors can easily follow your decision-making processes.
Staff Training for Inspection Behavior
Targeted coaching for operators, SMEs, QA, QPs, and leadership on how to respond clearly, confidently, and accurately to inspector questions.
Training includes communication protocols and handling high-pressure interactions.
Facility & Process Walkthroughs
On-site or virtual walkthroughs of manufacturing, QC, distribution, and support areas to ensure operational compliance before inspectors arrive.
Observation / Deficiency Response Support
Drafting, reviewing, and strengthening responses to Form 483s, FDA observations, EU inspection reports, or PIC/S findings.
Includes CAPA strategy, justification writing, and evidence preparation.
Inspection-Day Coaching & Support
Guidance for SMEs, QPs, RP, and leadership during the inspection: document control, escort roles, communication flow, and behavior in the inspection room.
Observation Management & Response Templates
Pre-approved templates and standardized response structures that accelerate reaction time and ensure regulatory accuracy when findings occur.
Inspection readiness doesn’t happen,
YOU build it.
Being prepared means more than passing an audit. It means protecting approvals, strengthening your quality system, and giving your teams the confidence to face any authority.
- Avoid regulatory setbacks
- Protect market access
- Preserve your reputation
- Strengthen quality systems
- Empower your teams
Stabilize. Strengthen. Transform.
We support organizations during critical transition periods by providing experienced pharmaceutical leaders, subject-matter experts, and structured methodologies to ensure continuity, compliance, and operational performance.
Transition
Strategic service plans built for your growth and long-term success
Experienced leaders step in immediately to maintain operational and regulatory continuity. Perfect for:
- Temporary vacancies (maternity leave, resignation, illness)
- Team restructuring
- Sudden workload increase
- Organizational change
We ensure uninterrupted QP, RP, and QA operations through structured backup models. Includes:
- Redundancy plans for QP/RP release
- Contingency strategies for critical operations
- Continuity risk assessments and mitigation plans
We elevate the capabilities of your internal teams. Focus areas:
- Mentorship for young QPs / new QA managers
- Leadership training for SME and operational teams
- Confidence & readiness coaching for regulatory interactions
Deployment of subject-matter experts in:
- MS&T (Manufacturing Science & Technology)
- Aseptic processing
- Contamination control
- Quality systems & data integrity
- Cold chain & distribution
We support teams in implementing efficient, modern workflows to strengthen performance:
- Value stream mapping
- Waste reduction & efficiency optimization
- Process simplification and digitization
- Continuous improvement culture
We guide your teams through structural, cultural, or operational transformations:
- New product introduction
- QMS modernization / eQMS implementation
- MIA preparation or scope extension
- Department restructuring
- Technology transfer transitions
We ensure clean, compliant, efficient systems during transitions:
- SOP creation and harmonization
- Training matrix redesign
- Role & responsibility definition
- Production line personnel training ("empty line" training)
If a project is failing or at risk, we step in to restore stability:
- Crisis assessment
- Rapid corrective action plan
- Leadership coordination
- KPI & dashboard implementation
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