Bringing a dietary supplement to market is a multi-step journey that requires careful planning, regulatory knowledge, and a reliable manufacturing partner. In this guide, we walk you through the complete OEM process from the initial formula to the finished product in your hands. Step 1: Concept and Formula Development It starts with an idea. What …
Bringing a dietary supplement to market is a multi-step journey that requires careful planning, regulatory knowledge, and a reliable manufacturing partner. In this guide, we walk you through the complete OEM process from the initial formula to the finished product in your hands.
Step 1: Concept and Formula Development
It starts with an idea. What health concern does your product address? Who is your target consumer? During this phase, you work with our R&D team to define health function and target claims, select active ingredients and dosages based on scientific evidence, determine the best dosage form, and design the formula with appropriate excipients for stability and bioavailability.
Step 2: Regulatory Review and Compliance Check
Before moving to production, we review the formula for regulatory compliance in your target market: United States (FDA 21 CFR Part 111, DSHEA labeling requirements), European Union (EFSA health claims authorization, Novel Food regulations), Australia (TGA listing requirements), United Kingdom (UK MHRA regulations), and Southeast Asia (country-specific FDA requirements).
Step 3: Sample and Prototype
We prepare a laboratory sample for your approval, including physical appearance (color, shape, size), taste and texture, disintegration and dissolution properties, and initial stability data.
Step 4: Packaging and Label Design
Packaging is where your brand comes to life. We offer label design, bottle printing (offset, silk screen, pressure-sensitive), child-resistant packaging, blister cards, pouches, and multi-pack formats with full regulatory compliance review.
Step 5: Manufacturing and Quality Control
Production Process: Raw Material Inspection – Blending – Encapsulation/Tableting/Gummy Cooking – In-Process Quality Checks – Primary Packaging – Secondary Packaging – Final Release Testing – Cold Chain Management.
Daily Production Capacity: 100 million hard capsules | 50 million softgels | 50 million tablets | 20 million gummies | 10 million sachets of powder.
Step 6: Documentation and Compliance Files
We provide Certificate of Analysis (CoA) for each batch, Certificate of Free Sale (CFS) for export clearance, Manufacturing Record (Batch Production Record), Certificate of Conformance, third-party lab reports, and MSDS.
Step 7: Shipping and Logistics
We support EXW, FOB, CIF, and DDP arrangements. Sea transit: 20-45 days to major ports worldwide. Full customs documentation support including commercial invoices, packing lists, and certificates of origin.
Typical Timeline
Formula development and regulatory review: 2-4 weeks | Sample preparation and approval: 2-3 weeks | Packaging design and approval: 2-3 weeks | Mass production: 2-4 weeks | QC and release: 1-2 weeks | Shipping: 2-6 weeks by destination.
Total: 9-22 weeks from concept to delivery.
Ready to Start Your Supplement Journey?
Email: wade@zuoningbio.com | Phone: +86 187 5469 6289 | Website: www.zuoningbio.com
