Advancing Innovation Through Smarter Quality
Whether you are preparing an IND, strengthening design and development controls, scaling an outsourced manufacturing model, establishing an effective quality system, or preparing for regulatory inspection, QualityWise brings the strategic perspective and hands-on expertise needed to move forward with confidence. The result is a practical, risk-based approach that protects patients, supports innovation, improves execution, and positions your organization for its next critical milestone.
At every stage where it matters most, QualityWise is here to help.
CONSULTING SERVICES
Where Smarter Quality Brings Regulatory Confidence
Offering Expertise and Initiative to deliver on your needs for:
New Product and Process Development
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Phase appropriate QMS
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Quality culture/ awareness
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GLP/ Toxicology/ Biocompatibility
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API/ Drug Substance and Drug Product
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Sterile/ Aseptic Manufacturing
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Chemistry, Manufacturing, and Controls
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Design Controls/ DHF/ DMR/ DHR
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Method Development and Qualification
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Verification & Validation/ MVP
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Equipment Qualification (IQ/OQ/PQ)
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Supplier Qualification & Audit
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pIND, IND, NDA, ANDA, IDE, 510K, PMA, CE/ Conformity Assessment
Quality Systems, GMP Manufacturing, and Performance Monitoring
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GMP Manufacturing Set-Up
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Batch Record Review/ Lot Disposition
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QC/ Laboratory testing, OOS/ Investigation
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NCR, sNCR, Deviation, CAPA,
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Complaint Handling and Investigation
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Risk Management
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Document Control
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Change Control
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Equipment Calibration, Preventive/ Corrective Maintenance
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Eliminate recurrent quality issues
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Bridge systems within/ across multiple sites
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Monitor and manage Suppliers US/ OUS
Audit, Remediation, and Continuous Improvement
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Gap Assessment
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Internal and Supplier Audit
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CRL/ DRL/ IRL/ GRL Response
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FDA / Notified Body Inspection Readiness and Support
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FDA 483 Response & Corrective Actions
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Lean/ Six Sigma Projects
Whether you are just starting to build a QMS, or looking to advance a culture of operational excellence, the expertise you need is just a click away.
24+
Years of Experience in Biotech, Medical Device, Pharmaceutical, and Combination Product
14+
Years of Experience in GxP Quality
12+
Years of Experience in R&D
100%
Applications Approved;
Quality problems solved;
483's resolved
ABOUT
Elana Levin
Quality and Regulatory Leader | Founder, QualityWise LLC
I am a Quality and Regulatory professional with more than 20 years of experience spanning biotechnology, pharmaceuticals, medical devices, and combination products. I hold an M.Sc. in Biological Sciences from the University of California, Irvine, am a Certified Lean Six Sigma Black Belt, and am currently pursuing a Doctorate of Professional Practice in Regulatory and Clinical Research Management at Arizona State University.
My career began in biotechnology research, investigating cancer biomarkers at a start-up in Santa Monica, California. I am especially proud that one of the discoveries emerging from that work ultimately contributed to an FDA-approved prostate cancer therapy. That experience gave me an early appreciation for the extraordinary journey from scientific discovery to a product that can meaningfully improve patients' lives.
I transitioned from bench research into regulated product development at Mentor Worldwide, a Johnson & Johnson company, designing and developing Class II and Class III medical devices. From there, my career expanded across medical devices, pharmaceuticals, biotechnology, and combination products, with each opportunity adding new technologies, regulatory frameworks, business challenges, and leadership responsibilities.
Over the course of my career, I have worked with organizations ranging from emerging biotech companies to global manufacturers and have supported products including:
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Antibody-conjugated nanoparticle diagnostic platforms
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Sterile injectables, prefilled syringes, and pen injectors
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Metered-dose inhalers and nasal sprays
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Class III injectable dermal fillers and breast implants
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Topical and transdermal pharmaceuticals
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Class II dialysis products and reusable surgical devices
My expertise spans Quality strategy, CMC and clinical Quality, phase-appropriate Quality Management Systems, design controls, Quality Risk Management, supplier and CDMO/CRO oversight, IND support, regulatory compliance, inspection readiness, and operational excellence. My regulatory experience includes FDA regulations, ICH Quality and Efficacy guidelines, GMP, GCP, GLP, QMSR, ISO 13485, ISO 9001, ISO 17025, PIC/S, EU GMP, and MDR requirements.
I founded QualityWise because I believe Quality should do more than ensure compliance—it should help organizations make better decisions, manage risk intelligently, accelerate development, and build systems that grow with their science.
I also believe strongly in supporting the next generation of scientists and innovators. QualityWise pledges 2% of my hourly consulting fees to Kid Spark Education, a 501(c)(3) nonprofit dedicated to expanding access to STEM education. Clients are also welcome to request that the contribution support another nonprofit organization.
Consulting engagements are available on a project, retainer, C2C, or W-2 basis. Rates generally range from $135 to $175 per hour, depending on project scope, complexity, and duration. Domestic and international travel and collaboration across multiple time zones are welcome.
Please visit my LinkedIn profile for additional details about my education, credentials, and professional experience. References are available upon request.
TESTIMONIALS
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Call or submit a request to discuss your consulting or contracting needs. All requests are answered within one business day!
