Pharmaco Consulting International
Unlocking Compliance solutions for your business
SERVICES
Compliance Innovations when they are needed
Computer System Validation
CSV
Quality/Data Compliance
Project Management
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. CAPA resolution in preparation for UK and EU inspections.
Our team have been involved in multiple capital projects (CAPEX) in the Pharmaceutical and Medical Device markets in Ireland and the UK. From input into the Design of facilities (BOD), P&ID, Site Master Files, Validation Master Plans, QA CSV and CQV documentation - Utilities, ISO 8 Cleanrooms, Microbiological and Chemical Laboratory design and development. Manufacturing, Product development, Method Validation and QA inspection of facilities. Government Audit facing for inspectorate, with multiple successful outcomes for clients.
OUR STORY
Innovating Life Science for a Healthier Tomorrow
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 on capital projects within Ireland on Delta V HFAT, VRTX FAT/SAT, commissioning and validation documentation.
Pharmaco Consulting 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
Our Life Science Advantages
Innovative Solutions
We offer cutting-edge innovations to meet diverse needs, timeline and drive advancements in various industries effectively.
Expert Team
Our skilled team excels in delivering exceptional life science services, ensuring precision, quality, and timely results for every project.
Global Impact
We contribute to the global life science landscape by developing sustainable solutions that positively impact communities and industries worldwide.
TESTIMONIALS
Client Testimonials
Glaxosmithkline - UK
Pharmaco Consulting International Ltd presented a knowledgeable contractor who integrated extremely well as part of a team. There was a commitment and dedication to finish tasks that were assigned, on time. Critical analytical instruments were successfully implemented which enabled us to realise our strategy going forward. Frequent project updates meant that there was no follow-up action required by GSK Management.
Pfizer - Ireland CSV/ASV Engineer
Pharmaco Consulting International Ltd feedback was as follows :-
Technical Ability - Excellent.
Quality of Work - Excellent.
Reliability - Excellent.
Interpersonal/People Skills - Very Good.
Strengths - Very thorough and follows instructions perfectly, very good at working under pressure and working to deadlines.
Areas for Development - None.
Univit - Northern Ireland
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 lead under the UK regulatory bodies. We highly recommend their services.
