The Power
of Good Quality
From early product development through clinical evaluation, market approval, and commercial manufacturing, Quality integration is critical to success and organizational longevity. But navigating how, how much, and when to implement Quality often leads to uncertainty. Even within mature organizations, the need for maintaining compliance with Quality regulations/ QMS or managing multiple suppliers, for example, can be overwhelming and lead to resource challenges.
For all the times you need it, QualityWise can help.
CONSULTING SERVICES
Quality without Compromise
Offering Expertise and Leadership 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/ ASL
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pIND, IND, NDA, ANDA, IDE, 510K, PMA, CE/ Conformity Assessment
Quality Systems, GMP Manufacturing, and Post Market Surveillance
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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 on a Quality journey or looking to bolster a team to drive change, the expertise you need is just a click away.
24+
Years of Experience in Biotech, Medical Device, Pharmaceutical, and Combination Product
12+
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
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M.Sc. Biological Sciences, UC-Irvine
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Over 20 years of Experience in Biotech, Medical Device, Pharmaceutical, and Combination Product industries.
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Certified Lean Six Sigma Black Belt
Upcoming:
Certified cGMP Professional (Exam Dec 2024)
Certified Quality Auditor (Exam Dec 2024)
Formal Training in Project Management, Risk Management, Emotional Intelligence
My journey to Quality started out initially in research, at a small biotech start-up in beautiful Santa Monica, CA, investigating cancer markers for urological, then reproductive, cancers. I am proud to say that one of our discoveries is now an FDA approved therapeutic for prostate cancer. It was there that I began to appreciate the long, arduous journey to product realization, starting humbly but excitedly from a concept in the laboratory.
My journey from bench research ramped up rather quickly when I took my first role in regulated industry at a Johnson & Johnson Company, designing and developing class II and class III medical devices. It was a "sink or swim" moment, and I prevailed in bringing my assigned products to market ahead of schedule, and being recognized with Encore awards as well as being designated an SME for design controls, technical writing, and more. Each role I attained after that- spanning medical device, pharmaceutical, and combination products- brought challenges of learning new regulations, new product lines, new teams, new dynamics, all which had to be navigated with aggressive timelines. With each role, I am became more comfortable and competent in driving fast-paced, dynamic, collaborative, and intentional teams/ environments, gaining the respect, trust, and confidence of colleagues as well as management.
Professional Product Portfolio in Brief:
Imagion Biosystems [Developer & CDMO]: cross regulated nanoparticle - antibody conjugate platform with initial iteration developed as a breast cancer diagnostic.
Tioga Research [CRO & CeDO]: multiple topical/ transdermal therapeutics, regulated as pharmaceuticals.
Allergan Aesthetics, an AbbVie Company [Developer & Manufacturer]: Class III Injectable Dermal Fillers.
Amphastar Pharmaceuticals [Developer & Manufacturer]: sterile injectable (prefilled syringes and pen injectors), nasal spray, and metered dose inhaler combination products.
Fresenius Medical Care NA [Manufacturer]: kidney dialysis consumables- powders and liquids; regulated as class II medical device, manufactured under GMP.
Mentor Worldwide LLC, a Johnson & Johnson Company [Developer & Manufacturer]: Class II reusable cannula, Class II reusable gel breast sizers, Class III gel breast implants.
Expertise in ICH (Q, E), 21CFR4, 21CFR210/211/GMP, 21CFR58/ GLP/ OECD, PIC/S, etc., 21CFR820/ QMSR/ ISO13485, ISO9001, ISO17025, MDR, Eudralex Vol. 4, and more.
Please visit my LinkedIn page to see full details of my education, training, and experience. References available upon request.
With my breadth of experience in start-ups to large companies, from R&D to Quality, it seemed a natural next step to start QualityWise to help organizations of all sizes and endeavors develop, deliver, and maintain products that are safe and effective, which add quality of life to their users. Additionally, starting QualityWise was an opportunity to contribute to future generations of curious and passionate Biotech, Pharma, and Medical Device professionals. I am happy to pledge a donation of 3% of my hourly fees to Kid Spark Education "a 501(c)3 nonprofit organization that believes every student deserves access to STEM education that can change their lives." (If you prefer another non-profit, please be sure to request!)
Rates generally between $125- $150, but will be based on project size, project scope, and duration.
C2C or W2 welcome
Available for travel and amenable to working with inter-national collaborators, suppliers, etc. in multiple time zones.
TESTIMONIALS
Let’s Work Together
Call or submit a request to discuss your consultation needs. All requests are answered within one business day!