Transform Your GMP Compliance Into a Competitive Advantage

World-Class CSV/CSA Excellence • FDA 21 CFR Part 11 • EU Annex 11 • GAMP 5

Don't let compliance failures cost you time and millions. Our battle-tested experts deliver guaranteed results that pass every audit, every time.

Quality

Quality


"Rigorous standards in every deliverable"

Loyality

Loyality


"Long-term partnerships built on trust"

Experience

Experience


"Deep industry knowledge you can rely on"

Support

Support


"Responsive guidance when you need it most"

Services

Comprehensive compliance services that eliminate risk and accelerate your path to market success.

We specialize in CSV/CSA validation, and quality assurance for GMP-regulated laboratories.

Our team brings deep expertise in pharmaceutical compliance, ensuring your operations meet the highest regulatory standards while maintaining operational efficiency.

From initial assessment to full implementation, we guide you through every step of the compliance journey.

Advanced CSV/CSA validation


Complete system validation mastery

Computer System Validation and Computer System Assurance expertise for all your digital systems and processes

Complete system validation mastery

FDA 21 CFR Part11, EU Annex 11 and GAMP5 compliance with bulletproof URS development, and flawless IQ/OQ/PQ execution. Zero compliance gaps guaranteed

Training Programs


Transform your team into compliance champions.

Customized training in CSV/CSA, GMP compliance, data integrity, and Quality Assurance. Interactive workshops designed for immediate implementation and lasting results.

 Training Programs

-Strategic compliance education

- Targeted training on GMP requirements, and GAMP5/CSV/CSA

Strategic Documentation Excellence


Documentation that wins audits

Comprehensive documentation services including SOPs, protocols, and regulatory submission support

Documentation that wins audits

Expert creation of GMP documentation including SOPs, Test Execution protocols, Validation Plans, Risk Assessments, Change Control procedures, plus Configuration Item Lists (CIL) and Configuration Specification (CS).

Data Integrity Excellence


Bulletproof data integrity programs.

MHRA, FDA, and EMA guideline implementation with risk-based CSV approaches, FMEA/FMECA analyses, and continuous monitoring systems that exceed regulatory expectations.

Data Integrity Excellence

-Comprehensive programs ensuring ALCOA+ principles

- Establishes robust data governance frameworks

Implements validation protocols and sustainable processes

- Protects data throughout lifecycle while meeting regulatory expectations

Audit-Ready Preparation


Pass every inspection with confidence.

QA audits, gap assessments, and ongoing compliance monitoring to ensure continuous regulatory alignment.

Pass every inspection with confidence.

Comprehensive audit preparation including mock audits, gap analyses, documentation reviews, and personnel training. FDA, EMA, and regulatory inspection readiness guaranteed.

Lifecycle Management Solutions


End-to-end system excellence.

Complete Change Control optimization, system lifecycle management from URS to retirement, ongoing maintenance, and periodic reviews of validated systems for sustained compliance.

Lifecycle Management Solutions

- End-to-end system support from validation through retirement

- Manages periodic reviews, change controls, and continuous monitoring

-Ensure sustained compliance while minimizing risk

Optimizes system performance throughout operational lifespan

About US

Elite Pharma Consulting ApS, a small specialized Danish consultancy firm with extensive expertise in pharmaceutical compliance, GAMP5/CSV/CSA and quality assurance.


We have built solid experience within GMP-regulated environments and understand the complex challenges that modern laboratories and production facilities face.


Our team comprises experienced specialists with backgrounds from leading pharmaceutical companies, combining deep technical knowledge with practical experience. This gives us a unique position to deliver tailored solutions that not only meet regulatory requirements but also optimize our clients' processes and operations.


We see ourselves as more than just consultants – we are your strategic partner in the journey toward full compliance and operational excellence.

Khalil Wali 

CEO and Founder

Khalil Wali

CEO and Founder

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Consultant

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Consultant

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Senior Consultant

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Senior Consultant

Our Team

"At Elite Pharma Consulting, we don't just solve compliance problems – we transform regulatory challenges into competitive advantages. Our mission is to empower pharmaceutical organizations with the expertise, tools, and confidence they need to excel in today's complex regulatory landscape. When you partner with us, you're not just getting consultants; you're gaining strategic allies committed to your success. We measure our achievement by yours – and we're dedicated to helping you reach new heights of operational excellence and regulatory compliance."


Khalil Wali - CEO & Founder, Elite Pharma Consulting ApS

4hrs

Average Response Time

$50M+

Compliance Costs saved

400+
Systems validated/ decommissioned

5+

Consultants

Why Elite Companies Choose Us

We don't just meet compliance standards – we set them. Here's what

makes us one of the undisputed leaders in pharmaceutical consulting.


Elite Pharma Consulting ApS represents the pinnacle of pharmaceutical compliance expertise.

Our team of world-class consultants brings decades of combined experience implementing FDA 21 CFR Part 11, EU Annex 11, PIC/S guidelines, and GAMP 5 principles across the globe's most demanding regulatory environments.

We've mastered every aspect of the compliance spectrum– from URS development and Risk Assessments to the most complex CSV projects, comprehensive Data Integrity programs, and high-stakes audit preparation. Our clients range from emerging biotechs to Fortune 500 pharmaceutical giants, all unified by their demand for excellence.

What sets us apart is our obsession with results. We don't just deliver compliance – we engineer competitive advantages. Our risk-based methodologies ensure optimal cost-effectiveness while our battle-tested processes guarantee regulatory success. When you partner with us, you're not just buying consulting – you're investing in market leadership.

Thank you for your interest in Elite Pharma Consulting

             - Feel free to fill out the form below, or contact us directly on +45 50147581

 
 
 
 
 
 
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