SERVICES
Our team specializes in Computer System Validation in the GXP environment to comply with the latest regulatory guidance 21 CFR Part 11, Annex 11, Eudralex Volume 4, 21 CFR Part 210, 21 CFR Part 211 and GAMP 5 Second Edition. Experience in Delta V Automation, VPE, Utility Systems, Manufacturing and Lab Systems.
Our team have been involved in multiple 483 resolution actions in conjunction with FDA assigned companies managing the 483. Site wide QMS system implementation in preparation for site inspection and approval by local authorities. Participation in site inspections with government regulatory bodies.
Our team have been involved in multiple capital projects (CAPEX) in the Pharmaceutical and Medical Device markets in Ireland. From input into the Design of facilities, Site Master Files, Validation Master Plan, QPEP development to Utility, Cleanroom, Lab design and development. Product development, Method Validation and inspection of facilities.
OUR STORY
PHARMACO CONSULTING was setup in 2009 to provide consultancy services to the Pharmaceutical and Medical Device business sectors within Ireland and the UK. The business was incorporated in 2015 as Pharmaco Consulting International Limited.
Each Life Science product and production facility must meet ever evolving procedures and standards which can be difficult to manage and implement.
Technical transfers, process validation, cleaning validations or new facility commissioning, can be harrowing for new or even seasoned pharmaceutical or medical teams. Experience in Commissioning, Qualification and Validation (CQV) are a must.
Validation of Automation systems play an ever increasing role in modern manufacturing processes. Pharmaco Consulting have worked directly with Emerson Automation systems Ireland on a capital project within Ireland on Delta V FAT/SAT pre validation documentation.
Pharmaco Consullting can provide that extra pair of hands when key staff need time off or have too many tasks to contend with in the allotted time scale.
WHY WORK WITH US
We offer cutting-edge innovations to meet diverse needs and drive advancements in various industries effectively.
Our skilled team excels in delivering exceptional life science services, ensuring precision, quality, and timely results for every project.
We contribute to the global life science landscape by developing sustainable solutions that positively impact communities and industries worldwide.
TESTIMONIALS
Pharmaco Consulting International Ltd's services have been instrumental in our success. Their dedication and knowledge are commendable.
Working with Pharmaco Consulting International Ltd has been a game-changer. Their expertise and professionalism exceeded our expectations.
Pharmaco Consulting International Ltd in Newry, UK and the Republic of Ireland, has provided Project Management Services on a CAPEX project. From site design and development to clean room design and CQV services. To site inspection support with the UK regulatory bodies. We highly recommend their services.