OEM & Contract
Manufacturing
Dedicated to Delivering Unparalleled Quality and Cost-Effective Products
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SOP, BOM & IFU Development
Cross-functional SOP development for manufacturing. Standardization of protocols and procedures into SOPs, BOMs, and instructions for use, with secure documentation and expert project guidance.
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Formulation, Filling & Capping
Formulation of solutions and buffers according to SOPs. Our facilities, which include a Filamatic high throughput liquid filling machine, can support jobs of any size. Bottle sizes ranging from 0.1 mL to 500 mL ± 0.5% filling accuracy for fluids of any viscosity.
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Quality Control for All Stages
Rigorous cross-functional QC procedures for raw materials, buffers, and final products. End-stage quality testing and batch release protocols. Full product traceability via batch records to meet industry standards.
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Product Specification Optimization
Conversion of R&D outputs into optimized product specs, including kit components, stability, and shipping validation.
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Procurement & Supplier Qualification
Sourcing of all chemicals, plastics, and components with supplier qualification.
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Custom Packaging & Labeling Design
Design and procurement of product packaging, including labels, artwork, and secure documentation.
Our Facilities
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32,000 square feet of full development labs and dedicated manufacturing quarters.
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ISO 9001:2015 and 13485:2016 certified. GMP-compliant with a robust Quality Management System.
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In-house formulation and cleanroom liquid filling with ISO-certified Class 7, 5, and 4 accuracy.
Here's How It Works
5 Steps to Start Your OEM or Contract Manufacturing Project
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Connect with Us
Reach out to discuss your project goals. After a quick discovery call, we'll review your requirements and initiate a mutual NDA.
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Planning & Quoting
We'll define kit specifications, minimum order quantity, required components, and label/packaging needs. A quote and supply agreement will be prepared for your review.
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Project Setup
Once approved, we'll open a dedicated project profile in our OEM system. It includes all documentation: SOPs, IFUs, contracts, labels, kit content forms, and call notes.
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Manufacturing Begins
Production takes place in our ISO 9001, 13485, and GMP-compliant facility, using validated cleanroom and filling procedures. QC protocols are applied to each batch.
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Delivery & Support
Your kits ship on schedule, and we stay in touch to provide post-delivery support, reorder coordination, and updates on any future improvements or revisions.
Start with Step 1
Connect with Us
We are dedicated to delivering unparalleled quality and cost-effective products, and have extensive experience in OEM and Contract Manufacturing where we have produced market-ready products to the highest of standards. A company built by scientists, for scientists, we are ready to assist you throughout the entire process: from conceptualization to commercialization.
- 25+ years of scientific manufacturing experience
- Full concept-to-commercialization support
- Secure project management & traceability
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