From discovery and formulation to process improvement, we have the experienced professionals you need to support your research and development projects.
Individual consultants, teams or managed projects with deliverables for:
- Product Development
- Method Validation
- Method Qualification
- Process Development
- Design Specification & Analysis
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)
- 510(k) Submissions
- Adverse Event Reports (AERs)
- European Medical Device Regulations (MDR)
Need support with your validation projects? Our consultants can help validate products, equipment, systems, software, facilities, utilities, test methods, processes and more.
Project Services
Individual consultants, teams or managed projects with deliverables for:
- Validation & Qualification
- Laboratory Equipment and Instrumentation
- Laboratory Information Management Systems (LIMS)
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.
Project Services
Individual consultants, teams or managed projects with deliverables for:
- Remediation
- Gap Assessment
- Risk Mitigation & Management
- Quality Systems Development/Improvement
- Corrective & Preventive Action (CAPA)
- Documentation
- Auditing
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.
Project Services
Individual consultants, teams or managed projects with deliverables for:
Program Management
- Validation
- Migration
- Risk Mitigation