Acceleration and Innovation in Research & Development
We help our clients improve productivity and reduce costs by applying specific focus on accelerating and innovating R&D, without sacrificing efficacy, budget, compliance, or safety.
To drive innovation in this way, we deliver subject matter experts, like specialized scientists and engineers, who work as individual contributors in support of successful R&D processes. We also deliver project managers who provide cross-functional core team leadership, building consensus and driving stage-gated R&D processes forward without surpassing budgets or timelines.
For medical devices, we support R&D from early concept through development, submission, launch, and lifecycle management. Our expertise extends across all types of medical devices, Class I through Class III, including robotics, high-volume consumables, complicated electromechanical devices, software as a medical device, and combination devices.
For pharmaceuticals, we work from concept to commercialization across a range of product types, including generic and branded, small molecule, biologics, gene therapies, translational medicine, different drug delivery methods, and vaccines.
Our Core Competencies
EG Life Sciences proudly provides access to the uppermost experts in the healthcare industry. Our project managers, subject matter experts, and client partners boast extensive experience in the following core areas:
- Audits and Audit Preparedness
- Cellular and Gene Therapies
- Clinical Evaluation Reports (CER)
- Clinical Trial Management
- Chemical, Manufacturing, and Controls (CMC)
- Computer System Validation (CSV)
- Engineering
- Medical Affairs
- Medical Writing
- Pipeline and Portfolio Management
- Quality Management Systems (QMS) Management
- Quality Assurance and Control
- Pre-Post Market Surveillance
- Regulatory Affairs Support
- Resource & Demand Management
- Risk Management
- Software as a Medical Device (SaMD)
- Statistical Analysis Software (SAS) / Statistical Programming
- SKU, Labeling
- Software Validation
- Standard Operating Procedures
- Supplier Quality
- Total Product Life Cycle
- EU MDR Risk Management and Compliance