Research & Development
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
- Analytical Development
- Process Development
- Formulation
- Design Specification & Analysis
Clinical Affairs
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.
Individual consultants, teams or managed projects with deliverables for:
- Biometrics
- CER Writing
- Medical Writing
- Clinical Operations
- Medical Affairs
Regulatory Affairs
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.
Individual consultants, teams or managed projects with deliverables for:
- 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)
Manufacturing
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.
Individual consultants, teams or managed projects with deliverables for:
- Product Assembly
- Packaging & Labeling
- Technology & Process Transfer
- Process Development & Optimization
- Sterilization & Purification
- Automation
One size does not fit all
and neither should your project solutions.
Whether it’s a single assignment or a project that requires oversight and deliverables, we provide you with the flexibility to quickly scale your team with the expertise you need. Explore your options.
Validation
Need support with your validation projects? Our consultants can help validate products, equipment, systems, software, facilities, utilities, test methods, processes and more.
Individual consultants, teams or managed projects with deliverables for:
- Standard Operating Procedures (SOPs)
- Master Validation Plans (MVPs)
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
Quality Assurance
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.
Individual consultants, teams or managed projects with deliverables for:
- Remediation
- Gap Assessment
- Risk Mitigation & Management
- Quality Systems Development/Improvement
- Corrective & Preventive Action (CAPA)
- Training
- Documentation
- Auditing
GxP Quality & Compliance
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.
- 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)
Individual consultants, teams or managed projects with deliverables for:
- Program Management
- Validation
- Migration
- Risk Mitigation
- Implementation
- Upgrades
- Customization
- Configuration
Facilities
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.
Individual consultants, teams or managed projects with deliverables for:
- Cost Control
- Scheduling
- Facility Expansion
- Design Management
- Construction Management
- Commissioning & Qualification
- Equipment Development
- Facility Set-Up & Inspection
