Met voortdurende veranderingen in regelgeving, technologische ontwikkelingen en de noodzaak om innovatieve producten op de markt te brengen, is het van groot belang dat u de juiste partner voor uw project kiest. Daarom koppelen we u aan het beste talent in staffing en consulting.
Lees meer over ons COVID-19-partnerverband met organisaties in biowetenschappen.
Klik hier voor een compleet overzicht van de branches waarin we actief zijn.
Van ontdekking en formulering tot procesverbetering: wij beschikken over de ervaren professionals die u nodig hebt voor onderzoek en ontwikkeling binnen uw bedrijf.
- Productontwikkeling
- Methodevalidatie
- Methodeontwikkeling
- Analytische ontwikkeling
- Procesontwikkeling en -validatie
- Formulering
- Design Specification & Analysis
- Quality Engineering
- mRNA
Onze consultants laboranten, analisten en consultants zijn snel inzetbaar en kunnen u ondersteunen bij alle laboratoriumwerkzaamheden en laboratoriumgerelateerde projecten. Dit behelst het uitvoeren van de analyses, maar ook het plannen, ontwerpen, upgraden of beheren van laboratoria, het leiden van wetenschappelijk en technologisch onderzoek en het uitvoeren van de experimenten en metingen die nodig zijn om de productkwaliteit te waarborgen.
- Kwaliteitscontrole
- Monstervoorbereiding
- Stabiliteitsonderzoek
- LIMS
- Microbiologie
- Biotechnologie/moleculaire biologie
- Analytische chemie
- Laboratoriummanagement en -coördinatie
- Sales / Commercieel
- Field Service Engineering
- Kwalificatie en validatie van laboratoriumapparatuur
Wilt u uw product snel op de markt brengen? Onze consultants voor klinisch onderzoek kunnen u bij elke stap begeleiden. We ondersteunen klinische proeven binnen allerlei specialismen.
- Klinische evaluatieverslagen (CER)
- Bio-informatica
- Preclinical studies
- Early phase studies
- Study start up/feasibility activities
- Clinical monitoring & oversight
- Clinical quality & Regulatory Affairs
- Contract- en budgetbeheer
- Clinical study nurses
- Data Entry/Managers & Study Coordinators (site based)
- Klinische artsen
Dankzij onze pool van medische consultants met diverse medische achtergronden kunnen we voor alle therapeutische vakgebieden experts inzetten.
- Medical Affairs
- Medical Information
- Medical Writing
- Market Access
- Health Economics
- Real World Data Management
- Medical Advisor
- Medical Manager
- Medical Liaison
Onze consultants spelen een sleutelrol in de gezondheidszorg door auditing, monitoring en identificatie van interacties tussen geneesmiddelen en hun effecten op mensen.
- EU- Qualified Person Responsible For Pharmacovigilance (QPPV) / Local-QPPV
- Periodieke veiligheidsverslagen (Periodic Safety Update Reports; PSUR's)
- Veiligheidsverslagen m.b.t. ontwikkeling (Development Safety Update Reports; DSUR's)
- Risk Management Plan
- Pharmacoepidemiology
- Literatuuronderzoek
In een gereguleerde omgeving is een foutloze strategie en uitvoering onmisbaar. Onze consultants ondersteunen uw planning, indiening, technische documentatie en herstel- en oplossingsbeheer, zodat u kunt voldoen aan wettelijke vereisten en gestelde deadlines.
- Premarket Approvals (PMA's)
- 510(k) Submissions
- Investigational Device Exemptions (IDE's)
- Investigational New Drug (IND) Applications
- Biological License Applications (BLA's)
- New Drug Applications (NDA's)
- Chemistry, Manufacturing & Controls (CMC) Submissions
- CE Mark
- Adverse Event Reports (AER's)
- European Medical Device Regulations (MDR)
- In Vitro Diagnostic Medical Device Regulations (IVDR)
- Clinical Evaluation Reports (CER's)
- Inspection Readiness
- ISO13485, ISO14971, IEC60601, IEC62304,
- ISO9001
- 21 CFR Parts 4, 11, 210, 610 en 820
Ondersteuning nodig bij uw engineeringprojecten? Onze consultants kunnen u helpen met CAPEX-, 'Greenfield'- en 'Brownfield'-projecten, uitbreidingen en technische overdrachten.
- Inbedrijfstelling, kwalificatie en validatie (Commissioning, Qualification & Validation; CQV)
- CAPEX-projectbeheer
- Verpakking en etikettering
- Foutmodus en effectenanalyse (Failure Mode and Effects Analysis; FMEA)
- Verwarming, ventilatie, airconditioning en nutsvoorzieningen
- Procestechniek
- Upstream- en downstreamproces
- Machinebouw
- Elektrotechniek
Hulp nodig bij uw productieactiviteiten en supply chain? Onze consultants kunnen u bij alle stappen van dienst zijn, van inkoop en goederenbeheer tot logistieke optimalisatie.
- Product Assembly
- Packaging & Labelling
- Technology & Process Transfer
- Lean 6 Sigma
- Process Development & Optimisation
- Sterilisation & Purification
- Automation
- Supply Chain
Onze consultants kunnen helpen bij het valideren van producten, apparatuur, systemen, software, faciliteiten, hulpprogramma's, testmethoden, processen en meer.
- Standard Operating Procedures (SOP's)
- Master Validation Plans (MVP's)
- Equipment Qualification
- Cleaning Validation
- Analytical Test Method Validation
- Verification & Validation
- Computer Systems Validation
De juiste procedures en processen zijn noodzakelijk om aan uw projecteisen te voldoen. Via ons netwerk van QA-experts ondersteunen wij klanten in hun zoektocht naar ongeëvenaarde aandacht voor kwaliteit bij hun sterk gereguleerde producten.
- Gap Assessment
- Risicobeperking en -beheer
- Ontwikkeling/verbetering van kwaliteitssystemen
- Corrigerende en preventieve acties
- Deviations Handling
- Klachtenafhandeling
- Training
- Documentatie
- Audits
- Batch Review
Voldoen uw systemen aan alle eisen, zoals die van 21 CFR Part 11 en EU Annex 11? Wij hebben het juiste talent dat gespecialiseerd is in de ondersteuning van technologische kwaliteit en naleving.
- Programmabeheer
- Validatie
- Migratie
- Risicobeperking
- Implementatie
- Upgrades
- Maatwerk
- Configuratie
- Quality Technology Agreements
- Quality Management (QMS)
- eQMS
- Electronic Document Management (EDMS)
- Laboratory Information Management (LIMS)
- Electronic Laboratory Notebooks (ELN)
- Scientific Data Management (SDMS)
- Clinical Trial Management (CTMS)
- Clinical Data Management (CDMS)
- Learning Management (LMS)
- Manufacturing Executions (MES)
- Building Management (BMS)
- Electronic Common Technical Docs (eCTD)
- Data Integrity (DI)
De klinische onderzoeksgegevens die uw organisatie creëert, zijn enorm waardevol. En alles wat u ermee doet, is belangrijk, of het nu gaat om het transformeren, opslaan of analyseren en valideren van deze gegevens. Onze consultants kunnen u ondersteunen bij de verschillende stappen en aspecten van databeheer in het kader van een klinische proef.
- Beheer van klinische studiegegevens
- eCRF-ontwerp en -validatie
- Ontwikkeling van klinische EDC-toepassingen
- Statistieken
- Biometrie
Oxford kan u ondersteunen bij alle stappen binnen de levenscyclus van systemen, van programmering tot inbedrijfstelling en van validatie tot naleving. We kunnen ook een leidende rol vervullen bij het uitrollen van uw IT-systemen naar andere locaties en landen.
- DCS
- PLC
- MES
- Allen Bradley/Siemens S7/Rockwell/Delta V
- Softwareontwikkeling en -configuratie
- Productieautomatisering
- Machineontwerp
- Ontwikkel- en validatieproces
- Computer Systems Validation
Scope and Objectives
Oxford Global Resources started a partnership with a multinational pharmaceutical company in 2018. Over the years, due to the quality outcomes, our teams have delivered, the client decided to make us an exclusive partner dedicated to supporting and guiding all medical education services across the organization, including the provision of a comprehensive service, responsibility for planning, delivery, and evaluation of professional programs in terms of operational outcomes, continuing professional development, induction, and skills training for juniors and trainees
Scope and Objectives
Oxford Global Resources started a partnership with a multinational pharmaceutical company in 2018. Over the years, due to the quality outcomes, our teams have delivered, the client decided to make us an exclusive partner dedicated to supporting and guiding all medical education services across the organization, including the provision of a comprehensive service, responsibility for planning, delivery, and evaluation of professional programs in terms of operational outcomes, continuing professional development, induction, and skills training for juniors and trainees.
Discover how Oxford provided the right talent to support a client’s global clinical trials.
A leading international pharmaceutical company was launching a vaccine for the COVID-19 virus and needed technical transfer and GxP support.
We assisted with Commissioning, Qualification, and Validation (CQV) support for a new facility expansion to support our client’s rapid growth. Learn how we delivered in spite of challenges.
A vocational university created a committee to assist their lab education department. Learn how Oxford provided invaluable perspective.
When our client needed to develop, manufacture, and distribute the COVID vaccine quickly and with high-quality results; they reached out to Oxford Global Resources for support.
AZ Sint-Maarten conducted a clinical trial for a COVID-19 vaccine. Due to the volume of volunteers, they would need more staff for an effective trial.
The COVID-19 pandemic required all governments, organizations, and individuals to work together in unprecedented ways. Discover how Oxford's support allowed an international testing laboratory to contribute to the Netherlands' efforts against the pandemic.
In the global efforts against COVID-19, widespread testing is key. Learn how Oxford helped Biogazelle quickly find the right talent to accommodate a large-scale testing initiative.
Our client, needed to convert more than 3,000 2D and 3D drawings and related specs of archived orthodontic products from a legacy Pro E CAD tool to SolidWorks™. With Oxford's partnership, learn how they achieved their goals.
In the fight against COVID-19, many organizations were asked to go above and beyond to help. One diagnostic organization was tasked by the government to assist in testing samples. Learn how Oxford helped them achieve their maximum daily capacity.
Discover how Oxford’s eight-year partnership with a CMO Management group allowed them to consistently achieve goals and expand their business.
Discover how Oxford assisted a microbiological testing company complete a backlog of analyses and uphold its commitments to its clients.
In order to pass an upcoming FDA inspection, our client needed specialized support. Discover how Oxford's partnership made the difference.
Discover how Oxford’s team of medical writers completed 150 scientific validity reports within five months.
Discover how Oxford helped a pharmaceutical manufacturer open a fully validated facility within eleven months.
A medical device manufacturer was in need of installing and qualifying a completely new piece of automated manufacturing equipment. Learn how Oxford's experts helped our client create a compliant system.
Discover how Oxford’s talent helped meet the deadline and complete the facility expansion.
Discover how Oxford promptly provided 15 consultants that were critical to achieving an observation-free site inspection.
Discover how Oxford’s consultants helped to remediate the issue and pass the FDA re-inspection.
Discover how Oxford provided assistance to keep the project on track.
Discover how Oxford consultants revised a Quality Management System to meet FDA regulations within seven weeks.
Discover how Oxford’s team helped create an FDA-compliant automated production process.
Discover how Oxford’s team quickly helped capture and address issues to achieve full compliance.
Discover how Oxford’s team of experts completed product-specific and State-of-the-Art Literature Searches within four months.
Discover how the right Oxford consultants were able to provide support for a Data Integrity Remediation project when a client needed niche expertise.
Discover how Oxford’s expert consultants enabled a smooth production process by reviewing six months of inaccurate data.
Discover how Oxford helped our client qualify 50 combination products in 3 years.
Discover how Oxford helped a medical device manufacturer start their MDR compliance journey the right way.
Due to a facility expansion, a global pharmaceutical manufacturer needed to engage with an organization that could provide Commissioning, Qualification and Validation services. Learn how Oxford delivered.