| Business Description: QUMAS, is the leader in Compliance and Quality Management Software Solutions with over 260 global customer deployments and 20 years’ experience in the Life Sciences sector. Our closed-loop Compliance Platform integrates common elements of compliance, content, processes, people and systems across the organization. QUMAS Solutions for document quality, incident and submission management and regulatory approval, enable organizations to accelerate time to market, decrease compliance risks, improve operational efficiencies and reduce overall quality costs. QUMAS is a Gold Microsoft Partner providing the QUMAS Compliance Platform on SharePoint 2010, Documentum, Oracle or SQL. |
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| Products & Services: The QUMAS Compliance Platform • Provides a closed-loop compliance & quality management solution, combining all elements of a comprehensive regulatory compliance program, on one platform • Delivers full capabilities around document & process management • Is accessed through a unified compliance user interface • Provides just-in-time learning management • Presents consolidated reporting & dashboards Core Capabilities include: • 21 CFR Part 11 compliance for electronic signatures and audit trail • Full document lifecycle state management • Controlled content creation based on configurable document templates with workflow automation, auto-naming and metadata support • Full traceability and accountability – including who viewed, reviewed and approved documents, key decision points and sign-off on compliance processes • Electronic forms for automation and processing of regulatory events such as CAPAs, Deviations, Change Control etc. |
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| Value Proposition: QUMAS offers proven regulatory compliance software solutions that help our Life Sciences customers to comply with global regulatory requirements. By choosing the QUMAS Compliance Platform our customers reduce the number of point solutions that need to be implemented and maintained, reducing costs and ultimately delivering enhanced business performance. The QUMAS Platform is easy to implement, easy to validate and easy to use. QUMAS also offers a number of Packaged Solutions providing pre-defined and pre-tested configurations of Document content management or Process management for specific,common industry problems. Each Package is designed to address a specific business function and includes all required software, implementation services, training, and documentation to support that business function. Packages may be combined and built upon over time as company requirements grow. QUMAS is ISO 9001: 2008 certified and has an extensive install-base of referencable clients. We have been audited by independent organizations such as the Parental Drug Association (PDA) and many of our leading clients. Customers frequently audit our systems against strict quality standards and guidelines, and we welcome the opportunity for independent audits by our clients. QUMAS has been successful in all customer audits to-date. Our quality assurance processes and software development methodology are based on the highest standards in the industry. |
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| Standards & Certification: Microsoft Gold Partner, ISO 9001:2008 |
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| Sector(s) Served: •ICT •Technology •Software •Life Sciences •Compliance, Legal & Regulatory •Bio Pharmaceutical •Research & Development |
Geographical Market(s) Served: Asia,Europe,Middle East,UKRegion,United States of America, South Africa |
| Key Customers: •Boehringer Ingelheim •GlaxoSmithKline •MedImmune •Takeda Pharmaceuticals •Actavis •Chiesi •EirGen •Millennium Pharmaceuticals •Vertex Pharmaceuticals •Purdue •Vistakon •Aspen Pharma •Samsung Biologics •Hollister •Shire Pharmaceuticals •Janssen •Basilea •Sigma Aldrich •Regeneron •Lantheus Medical Imaging |
Key Partners: •Microsoft •Oracle •Lexis Nexis •Cegedim •EXTEDO •Focused Consulting •US DataManagement •epistaIT •CTCLS •Adlib Software |
| Address: Cleve Business Park Monahan Road Cork |
Contact Details: Sales Contact: Ms. Julie Aherne Phone: +353 (021 – 4915100) eMail: info@qumas.com Website: www.qumas.com Social Media: |
QUMAS
Posted by on 18 April, 2012 in Compliance/Corporate Governance | Life Sciences | Pharma and Medical Device Services | Research & Development | Software - (Be the first to comment)PMI Software
Posted by on 16 April, 2012 in Biotechnology | Energy, Power & Utilities | Environment | Food & Beverages | IT For Health | Life Sciences | Local Government | Manufacturing | Pharma and Medical Device Services - (Be the first to comment)| Business Description: Since 1987, PMI Software has been enabling engineering, maintenance and facilities managers with software solutions to intelligently optimise the availability and safe maintenance of the assets of their organisations. Headquartered in Ireland, PMI Software offers the combination of leading technology in its PEMAC software suite, best practice asset management and the experience based knowledge of a 25 year track record in maintenance implementations for customers in Ireland, the United Kingdom and mainland Europe in the Life Sciences, Food & Drink, Retail, Energy and Facilities Sectors. |
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| Products & Services: PMI Software’s PEMAC product suite is established as the market leading Computerised Maintenance Management System (CMMS) operating in either stand alone environments or within an Enterprise Asset Management (EAM) or Enterprise Resource Planning (ERP) environments. PEMAC focuses on intelligent maintenance management, both planned and unplanned, utililising the enterprise wide and mobile workforce, condition based monitoring, preventative maintenance, and predictive maintenance models. With PEMAC, managers can develop and deliver maintenance best practice with Reliability Centred Maintenance (RCM), Total Productive Maintenance (TPM), Lean Maintenance and BSI PAS 55. The health and safety management of personnel and contractors in this process can be managed with PEMAC’s Permit to Work, Risk Assessment & Accident Report modules. |
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| Value Proposition: For engineering, maintenance and facilities managers who have limited time, resources and increasingly complex asset management needs, the PEMAC product suite from PMI Software unites deep maintenance experience, world class best management practice with the latest software technology to enable you to work smarter, faster and in real time by connecting all the people, assets and systems of your organisation for planning, scheduling and reporting so that data turns into the right insights at the right time for effective management. PEMAC customers have intelligently optimised the availability and safe maintenance of the assets of their organisations saving 60 – 80% in overall maintenance costs and achieving 99.2% uptime in operations. Our customers grow and drive their performance advantage higher in their organisations as we continually bring the latest management thinking and technologies through the PEMAC product suite and PMI Software support services |
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| Sector(s) Served: •ICT •Technology •Software •Manufacturing •Pharmaceutical •Medical Devices •Biotechnology •Food & Beverages •Energy •Waste •Buildings & Construction •Government & Public Bodies |
Geographical Market(s) Served: Ireland,England,Scotland,Wales,France, Germany,Belgium,TheNetherlands,Spain,Poland |
| Key Customers: •Cuisine de France •DewValley •Heineken •PepsicoIreland•Bulmers •Irish Distillers Group plc •Kerry Bioscience Ltd •Kerry Group •Carbery Milk •Nutricia Infant Nutrition Ltd •Wexford Creamery Ltd •Eircom •Proctor & Gamble •Tyco •Baxter Healthcare SA •Boston Scientific •Stryker •Elanco •Gerard Laboratories •Glaxo SmithKline •Leo Pharma •Schwarz Pharma •Stryker Instruments •Swords Laboratories •Trinity Biotech plc •Helsinn Birex Pharmaceuticals •Rottapharm |
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| Address: Unit 8 Kingswood Avenue Citywest Business Campus Dublin24 |
Contact Details: Sales Contact: Ms. Denise Kennedy Phone: +353 (01 – 4663888) eMail: info@pmisoftware.com Website: www.pmisoftware.com |
Brentech Data System
Posted by on 10 April, 2012 in Beverages | Dentistry | Distribution Software | Enterprise Resource Planning Software | IT For Health | Life Sciences | Medical Supplies | Pharma and Medical Device Services | Software | Supply Chain Management Software Provider | Veterinary - (Be the first to comment)| Business Description: Brentech Data Systems, an ISO 9001:2008 certified company, is a leading provider of Distribution, Supply Chain Management (SCM) and Enterprise Resource Planning (ERP) software and support to wholesalers and distributors of various sectors across the British Isles. Established since 1990, we have extensive experience in the provision of business critical software solutions to some of the largest wholesalers and distributors across Ireland and the United Kingdom including The Co-operative Pharmacy, Yodel, United Drug and Union Food Distributors. |
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| Products & Services: AWARDS-BA³ – Advanced Wholesale And Realtime Distribution System – is our leading software solution. It was developed according to the “best of breed” philosophy and built on the latest Microsoft®.NET technology platform to deliver a most advanced, future-proof business application. AWARDS-BA³ was designed to provide Business Agility, Business Automation and Business Alerts, and to become a complete and flexible solution to Distribution, SCM and ERP requirements. AWARDS-BA³ specializes in high volume automated environments and is capable of processing up to 1 million sales order lines per 8 hour day. AWARDS-BA³ also provides the latest GDP requirements, complying with recent EU legislation on traceability and delivery recording requirements, particularly those in the Healthcare Sector, covering Animal and Human Medicines, Equipment and OTC products to individual item level. |
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| Value Proposition: Brentech Data Systems is a leading provider of Distribution, Supply Chain Management (SCM) and Enterprise Resource Planning (ERP) software with over twenty years experience implementing software that can deliver up to 1 million sales order lines per 8 hour day. Our software system, AWARDS-BA³, allows wholesalers & distributors to manage the complexities of their inventory and distribution and streamline, adjust and control their business processes. We help wholesalers & distributors plan and implement our .NET ERP, SCM, Distribution software quickly and efficiently, ensuring minimum disruption and maximum ROI. This unique software enables companies to be extremely scalable and agile in today’s dynamic markets, to have full control over their business processes, and to have full, real-time visibility into business activities. Most importantly, AWARDS-BA³ also provides the latest GDP (Good Distribution Practice) requirements leading to the provision of full product traceability, easier legislative compliance, improved productivity and exceptional operational efficiency. With extensive experience in the provision of software solutions our outstanding team has the skills and knowledge to support our customers in all of their endeavours and ensure the resolution of any issues as quickly and efficiently as possible. Our pricing, which depends on the scope of the project, reflects the value of the system to our clients. Historically, customer implementations have seen a system payback within 6 months and an overall project payback within 24 months. Case studies, testimonials and 100% referencability from all of our customers provide extensive proof of our achievements over the last number of years. |
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| Standards & Certification: ISO 9001:2008 |
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| Sector(s) Served: •Technology •Software •Retail •Software Application •Healthcare Distributor •Healthcare •Pharmaceuticals •Enterprise Resource Planning Software •Medical Supplies •Beverage & Drink •Supply Chain Management Software |
Geographical Market(s) Served: Global |
| Key Customers: •The Co-operative Pharmacy •Abbot Laboratories •Irish Pharmacy Union •Yodel •Merit Pharmaceuticals •United Drug PLC •Pemberton •Craig & Hayward •Sangers(N.I)•Union Food Distributors •F.Maltby & Sons •Mawdsley-Brooks •Strathclyde Pharmaceuticals |
Key Partners: •Microsoft •Oracle •Progress |
| Address: 3 Ongar Square Dublin 15 |
Contact Details: Sales Contact: Ms Gerardine Farrell Phone: +353 (01 – 8270650) eMail: info@bds.ie Website: www.bds.ie Social Media: Google+ Youtube |
Compliance and Risk
Posted by on in Aerospace | Automotive | Compliance/Corporate Governance | Electronics | Energy, Power & Utilities | Life Sciences | Machinery | Manufacturing | Medical Devices | Pharma and Medical Device Services | Software | Sports | Telecommunications | Textiles - (Be the first to comment)| Business Description: Compliance & Risks is a leading source of global regulatory intelligence. We help you succeed in the everchanging complex regulatory environment. We provide innovative online tools that deliver the most timely and accurate global regulatory intelligence to emplower business compliance and success. |
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| Products & Services: Our innovative product C2P helps you succeed in the ever-changing complex regulatory environment. C2P is an online tool which delivers the most timely and accurate global regulatory intelligence to empower business compliance and success. Compliance and Risks provide expertise and services to support your regulatory processes. We can assist your company in monitoring regulations and other requirements globally. We can assess the risks these pose to your company and working with you can manage these risks across your operations. |
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| Value Proposition: We are a leading source of global regulatory intelligence. |
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| Sector(s) Served: •Technology •Software •Corporate •Aerospace •Automotive •Chemicals •Clothing •Defence •Electronics •Energy •Industry Associations •Medical devices •Outdoor Machinery •Telecommunications •Textiles •Manufacturing •Sports •Toys •Legal & Regulatory |
Geographical Market(s) Served: Belgium & Luxembourg,Canada,Denmark, England /Wales,France,Germany,Hong Kong,Hungary,Italy,Japan,Netherlands, Scotland,South Korea,Sweden, United States of America |
| Key Customers: •Apple •Boeing •Canon •Cisco •D&M PSS •Dell •Stanley •Dolby •EMC •Ericsson •GE •Hitachi •Honeywell•HP •IBM •Ikea •Johnson & Johnson •LEGO •LG •Mattel •Logitech •Microsoft •Mitsubishi Electric •Panasonic •Philips •Quantum •Samsung •Siemens •Sony Black & Decker •Stryker •Tyco •Whirlpool |
Key Partners: •Baker & McKenzie & ERA Technology |
| Address: Unit9 Eastgate Avenue EastgateBusinessPark LittleIsland Co Cork |
Contact Details: Sales Contact: Mr Sean Murphy Phone: +353 (021 – 4351990) eMail: info@complianceandrisks.com Website: www.complianceandrisks.com Social Media: |
SteriPack
Posted by on 7 March, 2012 in Life Sciences | Pharma and Medical Device Services - (Be the first to comment)SteriPack is a leading global supplier of Cleanroom Medical Packaging, Package Testing, Contract
Manufacturing and Contract Engineering Services for the Medical Device Industry Worldwide. SteriPack has a strong global presence with manufacturing facilities located in Ireland, Poland Malaysia and the USA and sales offices strategically located worldwide throughout Asia, Europe and The US.
Products & Services
SteriPack manufactures all products in class 7 and class 8 Cleanrooms and specializes in providing
customized products supplied to customers exacting specifications. The range of Packaging includes pouches, headerbags, blister lidding, rollstock, ziplock bags and Gusset Bags. Testing Services includes Analytical Testing, Package and Material Testing, Aging Testing and Transportation Testing.
Standards & Certifications
ISO 9001:2008, ISO 13485:2003, ISO 17025. Class 7 & Class 8 Cleanrooms.
Additional Languages
French, German, Malaysian, Mandarin. Italian, Polish, Spanish
Contact Name / Title
Barry Moore, Group Sales Director
Email bm@steripackgroup.com / info@steripackgroup.com
Web http://www.steripackgroup.com
Europe +353 57 9331888
Malaysia +60 3167 3596
USA + 1 (508) 520 9784
Intuition
Posted by on 10 December, 2008 in Capital Markets | Compliance/Corporate Governance | Education and e-Learning | Finance Sector | Learning | Life Sciences | Management | Pharma and Medical Device Services | Public Sector | Semi-state & Federal Government | Software | Support - (Be the first to comment)Intuition provides knowledge and learning services to the financial, pharmaceutical / life sciences and government sectors. Combining an intimate knowledge of these sectors with in-depth educational expertise, Intuition provides a full spectrum of products, services and technologies to support clients’ learning requirements.
Products/Services
• Healthcare courses: Infection control, decontamination.
• Generic Content: Health and safety training, security training.
• Learning management systems and hosting services.
• Consultancy, blended learning design, instructor-led training.
• Bespoke e-learning content.
Key Benefits
• End-to-end learning solutions: consultancy and programme design, development, web hosting and implementation services.
• Quality Accredited: ISO 9001:2000, UK TickIT.
• Public Sector Procurement Channels: A selection of government frameworks.
• Communicating policy effectively, standardising best practice and implementing regulatory standards.
Clients
Department of Health England, NHS, Ministry of Defence, Transport for
London, Ufi Learndirect, NHS Education Scotland, HM Treasury.
Partners
Microsoft Certified Partner, Research In Motion (Blackberry).
Standards & Certifications
Quality Management System ISO 9001:2000 certified, TickIT certified.
Additional Languages
English, French (including Canadian), Italian, German, Spanish (including Latin American), Dutch, Portuguese, Russian, Mandarin and Cantonese, Japanese, Korean.
Contact Name / Title
Séamus Coogan, Marketing Manager
Email
scoogan@intuition.com
Tel +353 (0)1 605 4300
Address
IFSC House, Custom House Quay, Dublin 1.
Zenith Technologies
Posted by on 16 March, 2008 in Life Sciences | Pharma and Medical Device Services - (Be the first to comment)Zenith provides high ‘value-added’ automation solutions to customers in the biotech, pharmaceutical, power and oil and gas sectors. Zenith works across all the major DCS and PLC platforms and is based in Cork with offices in the US, the UK, Singapore and India.
Products & Services
• Consultancy: FEED, project justifications, project health checks, system selection.
• Systems Integration: Across all major automation platforms.
• Training: Automation, IT, cGMP etc.
• Commissioning and qualification.
• Managed Services: Such as automation.
Clients
Novartis, GlaxoSmithKline, Pfizer, Merck, Wyeth.
Standards & Certifications
ISO 9001:2000
Additional Languages
German, French, Spanish, Italian, Hindi and Mandarin in regional offices.
Contact Name / Title
Brendan O’Regan, CEO
Email brendan.oregan@zenithtechnologies.com
Web www.zenithtechnologies.com
Tel +353 21 4370200
Address
Portgate Business Park, Ringaskiddy, Co. Cork.
TopChem (Pharmaceuticals and Laboratiroes)
Posted by on in Life Sciences | Pharma and Medical Device Services - (Be the first to comment)TopChem Laboratories Ltd. (est. 2000) and TopChem Pharmaceuticals Ltd. (est. 2007), both located in Ireland, offer a broad base of integrated outsourcing services including GMP manufacturing capability for Phase 1 and niche, small volume generic API products, to pharmaceutical, biotechnology and generic drug companies worldwide.
Products & Services
Laboratories:
• Research chemicals: (Own product list of 200 products).
• Reference: Standards and metabolites.
• Active Pharmaceutical Ingredients: R&D quantities of over 600 commercial products.
• Synthetic route selection and development/ Process R&D.
• Technical consultancy.
Pharmaceuticals:
• Development of API processes and products to order.
• Supply of qualification GMP batches.
• GMP manufacturing from grammes to 300 kg/year.
• Niche, low-volume generic APIs.
• Submission of DMFs: US, EU and other agencies.
• Support Services: (Reference standard impurities, metabolite, technical consultancy).
Contact Name / Title
Dónal Coveney, Managing Director
Email donal@topchempharma.com
Web www.topchem.ie
Tel +353 71 9189685
Address
Ballymote Business Park, Ballymote, Co. Sligo.
SL Controls
Posted by on in Life Sciences | Pharma and Medical Device Services - (Be the first to comment)SL Controls provides international consultancy, design, simulation and commissioning services for industrial automation equipment and control systems worldwide. SL Controls has a positive track record with large projects successfully completed for multi-national corporations, including companies in the biomedical and pharmaceutical industries.
Products & Services
SL Controls services are based around core strengths of:
• Automation: SL’s engineers have the experience and qualifications required to create a successful, compliant automation solution.
• Systems Integration: Experience and expertise in equipment integration allows the company to provide comprehensive solutions.
• Validation: SL’s core competencies in technology implementation is providing documentary evidence that the control system operates as specified.
• Overall Equipment Effectiveness: OEE is a way to monitor and improve the efficiency of manufacturing processes (i.e. machines, manufacturing cells, assembly lines).
Clients
Abbott Ireland, Wyeth Medica, Boston Scientific, Intel Ireland, Pfizer Ireland, Zogenix Incorporated, Nypro Ltd, Transitions Optical, Hewlett Packard, Henkel (Locktite), Davenham Ltd, Conaco – Philips, Baxter Healthcare, Mercury Engineering, The Quinn Group.
Standards & Certifications
ISO 9001:2000 certified, Microsoft Certified Partner.
Contact Name / Title
Darragh McMorrow, Finance and Contracts Manager
Email darragh.mcmorrow@slcontrols.com
Tel +353 71 9134040
Address
IDA Industrial Park, Collooney, Co. Sligo.
Sealpack
Posted by on 15 March, 2008 in Life Sciences | Pharma and Medical Device Services - (Be the first to comment)Sealpack is a leading supplier of quality labels and labelling systems to laboratories, hospitals and the medical device sector and has built and established long-term partnerships with customers based on professionalism, reliability and trust.
Products & Services
• Sealpack works closely with every client to ensure rapid service and high quality products.
Product range includes:
• Bar code labels (pre-printed).
• Variable information labels.
• Die cutting and punching specialists.
• Tamper evident and security labels.
• Hazard warning labels.
• Colour coded labels.
• Cryogenic labels.
• Blood pack labels and tags.
• Special adhesives for laboratory environment.
Clients
Medical device sector, laboratories, hospitals.
Standards & Certifications
ISO 9001:2000
Contact Name / Title
Joe Saul, Managing Director
Email joe@sealpack.ie
Web www.sealpack.ie
Tel +353 1 4534387
Address
Jamestown Industrial Centre, Inchicore, Dublin 8.
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