With constant regulatory changes, technology advancements, and the need to drive innovative products to market, having the right partner for your project is essential. That’s why we connect you to the highest caliber of talent for your staffing and consulting needs.
From discovery and formulation to process improvement, we have the experienced professionals you need to support your research and development projects.
- Product Development
- Method Validation
- Method Qualification
- Analytical Development
- Process Development
- Formulation
- Design Specification & Analysis
- mRNA
Learn more about our experience and how you can tap into our network for your specific initiative. Or, read industry insights and leverage additional resources on our blog.
When time is of the essence to get your product to market, our clinical affairs consultants can guide you every step of the way. We support clinical trials with a wide range of specialties.
- Biometrics
- CER Writing
- Medical Writing
- Clinical Operations
- Medical Affairs
- Bioinformatics
Learn more about our experience and how you can tap into our network for your specific initiative. Or, read industry insights and leverage additional resources on our blog.
In a regulated environment, having a flawless strategy and execution is imperative. Our consultants assist with planning, submissions, technical documentation, remediation and resolution management to help you meet regulatory requirements and deadlines.
- Premarket Approvals (PMAs)
- Investigational Device Exemptions (IDEs)
- Investigational New Drug (IND) Applications
- Biological License Applications (BLAs)
- New Drug Applications (NDAs)
- Chemistry, Manufacturing & Controls (CMC) Submissions
- 510(k) Submissions
- Adverse Event Reports (AERs)
- European Medical Device Regulations (MDR)
- In Vitro Diagnostic Medical Device Regulations (IVDR)
- Clinical Evaluation Reports (CERs)
- Inspection Readiness
Learn more about our experience and how you can tap into our network for your specific initiative. Or, read industry insights and leverage additional resources on our blog.
Looking for help with your supply chain and manufacturing operations? Our consultants can guide you through everything from sourcing and commodity management to logistics optimization.
- Product Assembly
- Packaging & Labeling
- Technology & Process Transfer
- Process Development & Optimization
- Sterilization & Purification
- Automation
Learn more about our experience and how you can tap into our network for your specific initiative. Or, read industry insights and leverage additional resources on our blog.
Need support with your validation projects? Our consultants can help validate products, equipment, systems, software, facilities, utilities, test methods, processes, and more.
- Standard Operating Procedures (SOPs)
- Master Validation Plans (MVPs)
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
Learn more about our experience and how you can tap into our network for your specific initiative. Or, read industry insights and leverage additional resources on our blog.
The right plans and processes are imperative to meeting your project requirements. Through our network of QA experts and additional Consulting Services, we help highly regulated products achieve unparalleled attention to quality.
- Remediation
- Gap Assessment
- Risk Mitigation & Management
- Quality Systems Development/Improvement
- Corrective & Preventive Action (CAPA)
- Training
- Documentation
- Auditing
Learn more about our experience and how you can tap into our network for your specific initiative. Or, read industry insights and leverage additional resources on our blog.
Do your systems meet requirements, such as 21 CFR Part 11 and Annex 11? We have the right talent specialized in supporting your technology based quality and compliance needs.
- Program Management
- Validation
- Migration
- Risk Mitigation
- Implementation
- Upgrades
- Customization
- Configuration
- Quality Management (QMS)
- 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)
Learn more about our experience and how you can tap into our network for your specific initiative. Or, read industry insights and leverage additional resources on our blog.
Whether you require a project manager for an equipment installation, a consultant who specializes in facility design, or a team-based approach for added oversight, we connect you to the qualified professionals you need to meet the demands of a GMP environment.
- Cost Control
- Scheduling
- Facility Expansion
- Design Management
- Construction Management
- Commissioning & Qualification
- Equipment Development
- Facility Set-Up & Inspection
Learn more about our experience and how you can tap into our network for your specific initiative. Or, read industry insights and leverage additional resources on our blog.
We have solutions to help you meet daily demands, while enhancing growth and innovation for your organization.
- IT Strategy
- Migration Services
- IT Security
- Software Development
- Digital Enterprise
- Support Services Center
- Workforce Management
- Centers of Excellence
- Solution Architects
- Developers
- Testing & QA Experts
- Business Analysts
- Project Managers
- Quality Engineers
- Manufacturing Engineers
- Chemical Engineers
Learn more about our experience and how you can tap into our network for your specific initiative. Or, read industry insights and leverage additional resources on our blog.
Our client needed additional technical support to lift and shift their IT infrastructure by the exit timeline as part of a divestiture.
Unique and dire circumstances called for sped-up vaccine production by experts skilled in automation and verification engineering.
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.