Biopharmaceutical Consulting

J+ You.

Seasoned quality assurance and engineering expertise, tailored to your timelines, your teams, and your goals.

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Trusted by industry leaders including

What We Do

End-to-end consulting
across the pipeline

Hands-on experience across clinical and commercial stages, working directly with FDA and supporting regulatory inspections.

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Quality Guidance

Up-to-date with industry standards. Deep experience with GMP, GLP, and FDA guidance across multi-site operations.

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Project Management

On schedule, clear communication. Complex projects across multiple pipeline phases with direct team-to-team coordination.

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Engineering & Process Design

Advanced degrees and deep biopharmaceutical experience — from process design to validation and commissioning.

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Audit Support

Expert preparation for regulatory inspections. Internal and external audit readiness with experienced guidance every step of the way.

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Documentation & Training

Robust SOPs, quality management systems, and training programs to ensure your team operates at their best.

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Device Development & Cold Chain

Strong background in drug substance, drug product, filling, packaging, and cold chain logistics — safe and secure delivery.

About J Plus

Seasoned expertise,
built for your timelines

J Plus (formerly Lucidyne) is a boutique consulting firm specializing in quality engineering and assurance for the biopharmaceutical industry. We provide both high-level advisory services and hands-on project execution — always with a direct line of communication to keep you fully informed.

20+
Years of industry experience
FDA
Inspection experience
Global
US, Europe & Asia projects
Both
Clinical & commercial stage
Jason Tong
Jason Tong
Founder · Senior Consultant

19+ years in the biopharmaceutical industry spanning qualification, cold chain, packaging design verification, project management, and CMO site management. Experience at Novartis, Roche, Genentech, Biogen (Apellis), Vertex, Intarcia Therapeutics, and Kindred Biosciences across clinical and commercial stages.

Project Management Commissioning & Qualification Cold Chain Packaging Design Verification Shipping Qualification CMO Management Risk Management Lane Risk Assessment SOP Writing
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Jeff Tong
Jeffrey Tong
Senior Consultant

27+ years of experience in the biopharmaceutical industry across the US, Europe, and Asia. Chemical Engineering degree from UCLA. Deep expertise spanning global risk management, cold chain, validation, drug substance, drug product, and quality management systems.

Quality Systems Engineering Risk Management Cold Chain SOP Writing
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Get in Touch

Let's talk about your project

Whether you need a single consultant or a full team for a critical deadline, we'd love to hear what you're working on.

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Email

contact@jplus.co

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Phone

510-457-1573

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Location

Orinda, CA