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.
 2020-2022 Pawe%c5%82 Kuna Permission is hereby granted%2c free of charge%2c to any person obtaining a copy of this software and associated documentation files (the 'Software')%2c to deal in the Software without restriction%2c including without limitation the rights to use%2c copy%2c modify%2c merge%2c publish%2c distribute%2c sublicense%2c and/or sell copies of the Software%2c and to permit persons to whom the Software is furnished to do so%2c subject to the following conditions: The above copyright notice and this permission notice shall be included in all copies or substantial portions of the Software. THE SOFTWARE IS PROVIDED 'AS IS'%2c WITHOUT WARRANTY OF ANY KIND%2c EXPRESS OR IMPLIED%2c INCLUDING BUT NOT LIMITED TO THE WARRANTIES OF MERCHANTABILITY%2c FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT. IN NO EVENT SHALL THE AUTHORS OR COPYRIGHT HOLDERS BE LIABLE FOR ANY CLAIM%2c DAMAGES OR OTHER LIABILITY%2c WHETHER IN AN ACTION OF CONTRACT%2c TORT OR OTHERWISE%2c ARISING FROM%2c OUT OF OR IN CONNECTION WITH THE SOFTWARE OR THE USE OR OTHER DEALINGS IN THE SOFTWARE. %3c/schema:copyrightNotice%3e%3c/rdf:Description%3e%3c/rdf:RDF%3e%3c/metadata%3e%3cpath d='M16.5 20.1667L22 25.6667L36.6667 11' stroke='%2397dae9' stroke-width='1.83333' stroke-linecap='round' stroke-linejoin='round'/%3e%3cpath d='M36.6667 22.0002V33.0002C36.6667 33.9726 36.2804 34.9053 35.5927 35.5929C34.9051 36.2805 33.9725 36.6668 33 36.6668H11C10.0275 36.6668 9.0949 36.2805 8.40727 35.5929C7.71964 34.9053 7.33333 33.9726 7.33333 33.0002V11.0002C7.33333 10.0277 7.71964 9.09507 8.40727 8.40744C9.0949 7.7198 10.0275 7.3335 11 7.3335H27.5' stroke='%2397dae9' stroke-width='1.83333' stroke-linecap='round' stroke-linejoin='round'/%3e%3c/svg%3e)
Quality
Quality
"Rigorous standards in every deliverable"
 2020-2022 Pawe%c5%82 Kuna Permission is hereby granted%2c free of charge%2c to any person obtaining a copy of this software and associated documentation files (the 'Software')%2c to deal in the Software without restriction%2c including without limitation the rights to use%2c copy%2c modify%2c merge%2c publish%2c distribute%2c sublicense%2c and/or sell copies of the Software%2c and to permit persons to whom the Software is furnished to do so%2c subject to the following conditions: The above copyright notice and this permission notice shall be included in all copies or substantial portions of the Software. THE SOFTWARE IS PROVIDED 'AS IS'%2c WITHOUT WARRANTY OF ANY KIND%2c EXPRESS OR IMPLIED%2c INCLUDING BUT NOT LIMITED TO THE WARRANTIES OF MERCHANTABILITY%2c FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT. IN NO EVENT SHALL THE AUTHORS OR COPYRIGHT HOLDERS BE LIABLE FOR ANY CLAIM%2c DAMAGES OR OTHER LIABILITY%2c WHETHER IN AN ACTION OF CONTRACT%2c TORT OR OTHERWISE%2c ARISING FROM%2c OUT OF OR IN CONNECTION WITH THE SOFTWARE OR THE USE OR OTHER DEALINGS IN THE SOFTWARE. %3c/schema:copyrightNotice%3e%3c/rdf:Description%3e%3c/rdf:RDF%3e%3c/metadata%3e%3cpath d='M32.6333 36.3312L28.6513 38.4175C28.5332 38.479 28.4002 38.5065 28.2674 38.4968C28.1345 38.4871 28.0069 38.4407 27.8989 38.3628C27.7909 38.2848 27.7067 38.1783 27.6557 38.0553C27.6047 37.9322 27.5888 37.7974 27.61 37.6659L28.3708 33.2457L25.1497 30.1162C25.0535 30.0233 24.9855 29.9051 24.9532 29.7754C24.921 29.6456 24.9259 29.5094 24.9674 29.3822C25.0089 29.2551 25.0853 29.1422 25.1878 29.0564C25.2904 28.9706 25.415 28.9154 25.5475 28.897L29.9988 28.2517L31.9898 24.2312C32.0494 24.1115 32.1412 24.0107 32.2548 23.9403C32.3685 23.8698 32.4996 23.8325 32.6333 23.8325C32.7671 23.8325 32.8982 23.8698 33.0118 23.9403C33.1255 24.0107 33.2173 24.1115 33.2768 24.2312L35.2678 28.2517L39.7192 28.897C39.8513 28.916 39.9754 28.9716 40.0775 29.0575C40.1796 29.1434 40.2557 29.2561 40.2971 29.3829C40.3385 29.5098 40.3436 29.6457 40.3117 29.7753C40.2799 29.9049 40.2125 30.023 40.117 30.1162L36.8958 33.2457L37.6548 37.664C37.6776 37.7958 37.663 37.9313 37.6126 38.0552C37.5623 38.179 37.4782 38.2863 37.3699 38.3648C37.2617 38.4432 37.1336 38.4898 37.0002 38.4991C36.8668 38.5084 36.7335 38.4802 36.6153 38.4175L32.6333 36.3312V36.3312Z' stroke='%2397dae9' stroke-width='1.4' stroke-linecap='round' stroke-linejoin='round'/%3e%3cpath d='M11.3667 36.3312L7.38466 38.4175C7.26649 38.479 7.13356 38.5065 7.00069 38.4968C6.86783 38.4871 6.74026 38.4407 6.63225 38.3628C6.52423 38.2848 6.44001 38.1783 6.38899 38.0553C6.33798 37.9322 6.32217 37.7974 6.34333 37.6659L7.10416 33.2457L3.883 30.1162C3.78685 30.0233 3.71878 29.9051 3.68654 29.7754C3.65431 29.6456 3.65921 29.5094 3.7007 29.3822C3.74218 29.2551 3.81857 29.1422 3.92115 29.0564C4.02373 28.9706 4.14837 28.9154 4.28083 28.897L8.73216 28.2517L10.7232 24.2312C10.7827 24.1115 10.8745 24.0107 10.9882 23.9403C11.1019 23.8698 11.2329 23.8325 11.3667 23.8325C11.5004 23.8325 11.6315 23.8698 11.7452 23.9403C11.8588 24.0107 11.9506 24.1115 12.0102 24.2312L14.0012 28.2517L18.4525 28.897C18.5846 28.916 18.7087 28.9716 18.8108 29.0575C18.913 29.1434 18.989 29.2561 19.0304 29.3829C19.0718 29.5098 19.0769 29.6457 19.0451 29.7753C19.0132 29.9049 18.9458 30.023 18.8503 30.1162L15.6292 33.2457L16.3882 37.664C16.4109 37.7958 16.3963 37.9313 16.346 38.0552C16.2956 38.179 16.2115 38.2863 16.1032 38.3648C15.995 38.4432 15.8669 38.4898 15.7335 38.4991C15.6001 38.5084 15.4668 38.4802 15.3487 38.4175L11.3667 36.3312V36.3312Z' stroke='%2397dae9' stroke-width='1.4' stroke-linecap='round' stroke-linejoin='round'/%3e%3cpath d='M22 17.9977L18.018 20.084C17.8998 20.1455 17.7669 20.173 17.634 20.1633C17.5012 20.1536 17.3736 20.1072 17.2656 20.0293C17.1576 19.9513 17.0734 19.8448 17.0223 19.7218C16.9713 19.5987 16.9555 19.4639 16.9767 19.3324L17.7375 14.9122L14.5163 11.7827C14.4202 11.6898 14.3521 11.5717 14.3199 11.4419C14.2877 11.3121 14.2926 11.1759 14.334 11.0487C14.3755 10.9216 14.4519 10.8087 14.5545 10.7229C14.6571 10.6371 14.7817 10.5819 14.9142 10.5635L19.3655 9.91821L21.3565 5.89771C21.4161 5.77796 21.5078 5.6772 21.6215 5.60677C21.7352 5.53634 21.8663 5.49902 22 5.49902C22.1337 5.49902 22.2648 5.53634 22.3785 5.60677C22.4922 5.6772 22.584 5.77796 22.6435 5.89771L24.6345 9.91821L29.0858 10.5635C29.2179 10.5825 29.342 10.6381 29.4442 10.724C29.5463 10.8099 29.6224 10.9226 29.6638 11.0494C29.7052 11.1763 29.7102 11.3122 29.6784 11.4418C29.6466 11.5714 29.5791 11.6895 29.4837 11.7827L26.2625 14.9122L27.0215 19.3305C27.0443 19.4623 27.0297 19.5978 26.9793 19.7217C26.9289 19.8455 26.8449 19.9528 26.7366 20.0313C26.6283 20.1097 26.5002 20.1563 26.3669 20.1656C26.2335 20.1749 26.1001 20.1467 25.982 20.084L22 17.9977V17.9977Z' stroke='%2397dae9' stroke-width='1.4' stroke-linecap='round' stroke-linejoin='round'/%3e%3c/svg%3e)
Loyality
Loyality
"Long-term partnerships built on trust"
 Copyright (c) 2013-2017 Cole Bemis Permission is hereby granted%2c free of charge%2c to any person obtaining a copy of this software and associated documentation files (the 'Software')%2c to deal in the Software without restriction%2c including without limitation the rights to use%2c copy%2c modify%2c merge%2c publish%2c distribute%2c sublicense%2c and/or sell copies of the Software%2c and to permit persons to whom the Software is furnished to do so%2c subject to the following conditions: The above copyright notice and this permission notice shall be included in all copies or substantial portions of the Software. THE SOFTWARE IS PROVIDED 'AS IS'%2c WITHOUT WARRANTY OF ANY KIND%2c EXPRESS OR IMPLIED%2c INCLUDING BUT NOT LIMITED TO THE WARRANTIES OF MERCHANTABILITY%2c FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT. IN NO EVENT SHALL THE AUTHORS OR COPYRIGHT HOLDERS BE LIABLE FOR ANY CLAIM%2c DAMAGES OR OTHER LIABILITY%2c WHETHER IN AN ACTION OF CONTRACT%2c TORT OR OTHERWISE%2c ARISING FROM%2c OUT OF OR IN CONNECTION WITH THE SOFTWARE OR THE USE OR OTHER DEALINGS IN THE SOFTWARE. %3c/schema:copyrightNotice%3e%3c/rdf:Description%3e%3c/rdf:RDF%3e%3c/metadata%3e%3cpath d='M14.8724 19.6231C14.8724 18.8321 15.1554 18.0672 15.6702 17.4666L23.6078 8.20605C24.3163 7.37948 25.4964 7.14117 26.4702 7.62803C27.4208 8.10337 27.8773 9.20542 27.5412 10.2138L24.8133 18.3973H32.4406C32.6394 18.3973 32.8378 18.4152 33.0334 18.4508C34.8339 18.7782 36.0282 20.5032 35.7008 22.3037L33.5921 33.9014C33.3057 35.4771 31.9334 36.6223 30.3319 36.6223H18.1861C16.356 36.6223 14.8724 35.1388 14.8724 33.3087V19.6231Z' stroke='%2397dae9' stroke-width='1.83' stroke-linecap='round' stroke-linejoin='round'/%3e%3cpath d='M8.24518 34.9655V20.0542' stroke='%2397dae9' stroke-width='1.83' stroke-linecap='round' stroke-linejoin='round'/%3e%3c/svg%3e)
Experience
Experience
"Deep industry knowledge you can rely on"
 Copyright (c) 2013-2017 Cole Bemis Permission is hereby granted%2c free of charge%2c to any person obtaining a copy of this software and associated documentation files (the 'Software')%2c to deal in the Software without restriction%2c including without limitation the rights to use%2c copy%2c modify%2c merge%2c publish%2c distribute%2c sublicense%2c and/or sell copies of the Software%2c and to permit persons to whom the Software is furnished to do so%2c subject to the following conditions: The above copyright notice and this permission notice shall be included in all copies or substantial portions of the Software. THE SOFTWARE IS PROVIDED 'AS IS'%2c WITHOUT WARRANTY OF ANY KIND%2c EXPRESS OR IMPLIED%2c INCLUDING BUT NOT LIMITED TO THE WARRANTIES OF MERCHANTABILITY%2c FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT. IN NO EVENT SHALL THE AUTHORS OR COPYRIGHT HOLDERS BE LIABLE FOR ANY CLAIM%2c DAMAGES OR OTHER LIABILITY%2c WHETHER IN AN ACTION OF CONTRACT%2c TORT OR OTHERWISE%2c ARISING FROM%2c OUT OF OR IN CONNECTION WITH THE SOFTWARE OR THE USE OR OTHER DEALINGS IN THE SOFTWARE. %3c/schema:copyrightNotice%3e%3c/rdf:Description%3e%3c/rdf:RDF%3e%3c/metadata%3e%3cpath d='M20.1667 12.368L17.2742 10.9218C16.7651 10.6672 16.2036 10.5347 15.6344 10.5347H14.3521C13.3797 10.5347 12.447 10.921 11.7594 11.6086L10.2406 13.1274C9.55297 13.815 9.16667 14.7476 9.16667 15.7201V25.0723C9.16667 26.2982 9.77937 27.4431 10.7994 28.1231L17.8887 32.8493C19.2397 33.7502 21.0225 33.6548 22.2699 32.6153L31.1667 25.2013' stroke='%2397dae9' stroke-width='1.83' stroke-linecap='round' stroke-linejoin='round'/%3e%3cpath d='M26.5007 21.3774C25.3944 19.896 23.3585 19.4702 21.7512 20.3835L18.3498 22.3168C17.2571 22.9377 15.8842 22.7522 14.9955 21.8636C13.8344 20.7023 13.9209 18.7949 15.1824 17.7439L22.8135 11.3845C23.4725 10.8354 24.303 10.5347 25.1609 10.5347H26.6345C27.2037 10.5347 27.7651 10.6672 28.2742 10.9218L32.8064 13.1879C34.0487 13.809 34.8333 15.0786 34.8333 16.4675V21.4973C34.8333 25.0248 30.3397 26.5177 28.2289 23.6914L26.5007 21.3774Z' stroke='%2397dae9' stroke-width='1.83' stroke-linecap='round' stroke-linejoin='round'/%3e%3cpath d='M1.83333 28.8677V12.3677' stroke='%2397dae9' stroke-width='2' stroke-linecap='round' stroke-linejoin='round'/%3e%3cpath d='M1.83333 28.8677V12.3677' stroke='%2397dae9' stroke-width='1.83' stroke-linecap='round' stroke-linejoin='round'/%3e%3cpath d='M42.1667 28.8677V12.3677' stroke='%2397dae9' stroke-width='1.83' stroke-linecap='round' stroke-linejoin='round'/%3e%3c/svg%3e)
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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Coming soon
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
 2020-2022 Pawe%c5%82 Kuna Permission is hereby granted%2c free of charge%2c to any person obtaining a copy of this software and associated documentation files (the 'Software')%2c to deal in the Software without restriction%2c including without limitation the rights to use%2c copy%2c modify%2c merge%2c publish%2c distribute%2c sublicense%2c and/or sell copies of the Software%2c and to permit persons to whom the Software is furnished to do so%2c subject to the following conditions: The above copyright notice and this permission notice shall be included in all copies or substantial portions of the Software. THE SOFTWARE IS PROVIDED 'AS IS'%2c WITHOUT WARRANTY OF ANY KIND%2c EXPRESS OR IMPLIED%2c INCLUDING BUT NOT LIMITED TO THE WARRANTIES OF MERCHANTABILITY%2c FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT. IN NO EVENT SHALL THE AUTHORS OR COPYRIGHT HOLDERS BE LIABLE FOR ANY CLAIM%2c DAMAGES OR OTHER LIABILITY%2c WHETHER IN AN ACTION OF CONTRACT%2c TORT OR OTHERWISE%2c ARISING FROM%2c OUT OF OR IN CONNECTION WITH THE SOFTWARE OR THE USE OR OTHER DEALINGS IN THE SOFTWARE. %3c/schema:copyrightNotice%3e%3c/rdf:Description%3e%3c/rdf:RDF%3e%3c/metadata%3e%3cpath d='M36.6667 7.3335H7.33333C6.32081 7.3335 5.5 8.15431 5.5 9.16683V27.5002C5.5 28.5127 6.32081 29.3335 7.33333 29.3335H36.6667C37.6792 29.3335 38.5 28.5127 38.5 27.5002V9.16683C38.5 8.15431 37.6792 7.3335 36.6667 7.3335Z' stroke='%2397dae9' stroke-width='1.83333' stroke-linecap='round' stroke-linejoin='round'/%3e%3cpath d='M12.8333 36.6665H31.1667' stroke='%2397dae9' stroke-width='1.83333' stroke-linecap='round' stroke-linejoin='round'/%3e%3cpath d='M16.5 29.3335V36.6668' stroke='%2397dae9' stroke-width='1.83333' stroke-linecap='round' stroke-linejoin='round'/%3e%3cpath d='M27.5 29.3335V36.6668' stroke='%2397dae9' stroke-width='1.83333' stroke-linecap='round' stroke-linejoin='round'/%3e%3cpath d='M22 20.556C24.4118 20.556 26.3669 18.6009 26.3669 16.1892C26.3669 13.7774 24.4118 11.8223 22 11.8223C19.5882 11.8223 17.6331 13.7774 17.6331 16.1892C17.6331 18.6009 19.5882 20.556 22 20.556Z' stroke='%2397dae9' stroke-width='1.2' stroke-linecap='round' stroke-linejoin='round'/%3e%3cpath d='M22.0014 20.5586L24.476 24.8447L25.6391 22.4923L28.2578 22.6612L25.7832 18.3751' stroke='%2397dae9' stroke-width='1.2' stroke-linecap='round' stroke-linejoin='round'/%3e%3cpath d='M18.2168 18.375L15.7422 22.6611L18.3609 22.4922L19.524 24.8445L21.9986 20.5584' stroke='%2397dae9' stroke-width='1.2' stroke-linecap='round' stroke-linejoin='round'/%3e%3c/svg%3e)
400+
Systems validated/ decommissioned
 2020-2022 Pawe%c5%82 Kuna Permission is hereby granted%2c free of charge%2c to any person obtaining a copy of this software and associated documentation files (the 'Software')%2c to deal in the Software without restriction%2c including without limitation the rights to use%2c copy%2c modify%2c merge%2c publish%2c distribute%2c sublicense%2c and/or sell copies of the Software%2c and to permit persons to whom the Software is furnished to do so%2c subject to the following conditions: The above copyright notice and this permission notice shall be included in all copies or substantial portions of the Software. THE SOFTWARE IS PROVIDED 'AS IS'%2c WITHOUT WARRANTY OF ANY KIND%2c EXPRESS OR IMPLIED%2c INCLUDING BUT NOT LIMITED TO THE WARRANTIES OF MERCHANTABILITY%2c FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT. IN NO EVENT SHALL THE AUTHORS OR COPYRIGHT HOLDERS BE LIABLE FOR ANY CLAIM%2c DAMAGES OR OTHER LIABILITY%2c WHETHER IN AN ACTION OF CONTRACT%2c TORT OR OTHERWISE%2c ARISING FROM%2c OUT OF OR IN CONNECTION WITH THE SOFTWARE OR THE USE OR OTHER DEALINGS IN THE SOFTWARE. %3c/schema:copyrightNotice%3e%3c/rdf:Description%3e%3c/rdf:RDF%3e%3c/metadata%3e%3cpath d='M7.79277 11.0218C9.81781 11.0218 11.4594 9.38019 11.4594 7.35514C11.4594 5.3301 9.81781 3.68848 7.79277 3.68848C5.76772 3.68848 4.1261 5.3301 4.1261 7.35514C4.1261 9.38019 5.76772 11.0218 7.79277 11.0218Z' stroke='%2397dae9' stroke-width='1.83333' stroke-linecap='round' stroke-linejoin='round'/%3e%3cpath d='M4.12612 38.5212V29.3545L2.29279 27.5212V20.1878C2.29279 19.7016 2.48594 19.2353 2.82976 18.8915C3.17357 18.5476 3.63989 18.3545 4.12612 18.3545H11.4595C11.9457 18.3545 12.412 18.5476 12.7558 18.8915C13.0996 19.2353 13.2928 19.7016 13.2928 20.1878V27.5212L11.4595 29.3545V38.5212' stroke='%2397dae9' stroke-width='1.83333' stroke-linecap='round' stroke-linejoin='round'/%3e%3cpath d='M36.2714 11.0218C38.2964 11.0218 39.9381 9.38019 39.9381 7.35514C39.9381 5.3301 38.2964 3.68848 36.2714 3.68848C34.2464 3.68848 32.6047 5.3301 32.6047 7.35514C32.6047 9.38019 34.2464 11.0218 36.2714 11.0218Z' stroke='%2397dae9' stroke-width='1.83333' stroke-linecap='round' stroke-linejoin='round'/%3e%3cpath d='M32.6048 38.5212V29.3545L30.7714 27.5212V20.1878C30.7714 19.7016 30.9646 19.2353 31.3084 18.8915C31.6522 18.5476 32.1185 18.3545 32.6048 18.3545H39.9381C40.4243 18.3545 40.8906 18.5476 41.2345 18.8915C41.5783 19.2353 41.7714 19.7016 41.7714 20.1878V27.5212L39.9381 29.3545V38.5212' stroke='%2397dae9' stroke-width='1.83333' stroke-linecap='round' stroke-linejoin='round'/%3e%3cpath d='M22.0321 12.8118C24.0571 12.8118 25.6988 11.1702 25.6988 9.14518C25.6988 7.12014 24.0571 5.47852 22.0321 5.47852C20.007 5.47852 18.3654 7.12014 18.3654 9.14518C18.3654 11.1702 20.007 12.8118 22.0321 12.8118Z' stroke='%2397dae9' stroke-width='1.83333' stroke-linecap='round' stroke-linejoin='round'/%3e%3cpath d='M18.3655 40.3122V32.9788H14.6988L18.3655 21.9788C18.3655 21.4926 18.5586 21.0263 18.9024 20.6825C19.2462 20.3387 19.7126 20.1455 20.1988 20.1455H23.8655C24.3517 20.1455 24.818 20.3387 25.1618 20.6825C25.5056 21.0263 25.6988 21.4926 25.6988 21.9788L29.3655 32.9788H25.6988V40.3122' stroke='%2397dae9' stroke-width='1.83333' stroke-linecap='round' stroke-linejoin='round'/%3e%3c/svg%3e)
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
