YOU HANDLE THE RESEARCH, WE HANDLE THE REST!
Services
Online Operations Consultation
Online Operations Consultation
Online Operations Consultation
Are you a startup lab needing a lab space build or quality representation? Are you an established firm looking for an efficient solution to a pressing problem? Our team has over 30 years of combined lab experience from various disciplines. Let us earn your business!
Strategic Plans
Online Operations Consultation
Online Operations Consultation
We understand your need to balance saving money with accomplishing your goals in a timely and compliant manner. Striking this balance can be tough when your research is complex or highly specialized. We will empower you with multiple options.
Let us propose different paths to best fit your firm's needs!
Eliminate Your Risk
Online Operations Consultation
Eliminate Your Risk
We reference information from numerous recognized governing bodies and advocacy organizations. These include federal regulations, FDA, ISO, ICH, CLSI, IASSC, ASQ, ASCP, Lean Six Sigma and more!
Let us prove our value!
Services List
Operational Efficiency
- Lab Builds and Reorganization
- Key Performance Indicators
- Project Management
- Labspace Optimization
- 3D Lab Builds
- Outside Vendor Collaboration
- Quality Vendor Management
- Safety Training
- Proficiency Testing
- Lean Six Sigma Analysis/ Implementation
- Supply Chain Concerns
- Complaint Review/ Dispute Resolution
- Asset Tracking
- Internal Reviews
- Mock Audits
Quality Representation
- Quality Assurance Guidance
- SOP Writing
- Inspection Readiness
- Quality Vendor Strategy and Negotiations
- Risk Assessment and IQCP Development
- Controls Reviews
- Stability Testing
- Reserve Sample Strategy
- Documentation Review
- Sampling Strategies
- QC Testing
- Metrological Monitoring
- Equipment Calibration
- Validations and Verifications
- Change Management Review
- Audits
- Deviations/ Non-Conformity Handling
- CAPA Establishment
- Inventory Management
- QMS Builds
Good Practices
- Current Good Manufacturing Practice (cGMP)
- Good Clinical Practice (GCP) from EMA
- Good Lab Practice (GLP)
- Good Documentation Practice (GDocP)
- Good Distribution Practice (GDP)
- Quality Management System
- ALCOA Analysis
Compliance Help
- CFR Title 21
- CFR Title 42, Chapter IV
- ISO 9000 Family
- ISO 45000 Family
- ISO/IEC 17025
- ISO 19011
- ICH Guideline Implementation
- FDA Inspection Representation
- CLIA Gap Analysis
- CLIA Build, Accreditation and Certification
- CAP Accreditation
Reach Out And Say Hello!
This list is merely a premise to the depth of our story. We love to talk science, and would love to hear what you have to say. Reach out for a no cost consultation. We want to earn your trust!