Dietary Supplement Manufacturing & Export FAQ

REGULATORY COMPLIANCE AND PRODUCT CERTIFICATION

Has the facility obtained GMP and ISO 22000 certifications?

Does the product comply with target market regulatory requirements?

Can the factory provide ingredient safety documentation?

Does the factory have valid export certifications and cross-border logistics experience?

Yes, our factory holds comprehensive export certifications and has extensive cross-border logistics expertise to ensure seamless global distribution. Here’s a detailed overview:

We maintain internationally recognized certifications critical for compliance and market access.
We partner with leading logistics providers to optimize efficiency and compliance:
- Multi-Modal Transport:
  - Air Freight: Fast-track delivery via dedicated cargo routes.
  - Ocean & Rail: Cost-effective bulk shipping with customs pre-clearance support.
- Customs Compliance:
  - Automated documentation for real-time tracking and reduced clearance delays.
  - Expertise in handling country-specific requirements.

QUALITY MANAGEMENT AND CONTROL SYSTEM(QMCS)

How to ensure product ingredient consistency and stability testing?

To ensure ingredient consistency and stability in our dietary supplements, we implement a rigorous, science-driven protocol aligned with FDA, EU, and ICH (International Council for Harmonisation) guidelines. Here’s our systematic approach:

Supplier Compliance: All raw material suppliers undergo strict audits (ISO 22000 criteria) and must provide Certificates of Analysis (CoA) with purity, potency, and contaminant testing (e.g., heavy metals, microbials).
Standardized Production: GMP-mandated batch records, validated equipment, and real-time monitoring (e.g., humidity, temperature) ensure uniformity across tablet hardness, capsule fill weight, or powder blend homogeneity.
Accelerated & Real-Time Stability Studies
- Accelerated Testing: Products are stored at 40°C/75% RH for 6 months to simulate 2–3 years of shelf life, with checks for degradation, discoloration, or dissolution changes.
- Long-Term Testing: Ongoing 25°C/60% RH studies validate expiration dates and detect drift in potency (e.g., vitamins, probiotics).
- Climatic Zone Adaptability: Customized stability protocols for Zone II (EU/USA) or IV (tropical markets) to ensure global compliance.
Traceability & Documentation: Full documentation of raw material lot numbers, manufacturing dates, and stability results for audit readiness.
Custom Formulation Support
- Our R&D team preempts stability risks during product design by:
- Selecting excipients compatible with actives (e.g., avoiding moisture-sensitive ingredients in gummies).
- Validating packaging (e.g., UV-blocking bottles for light-sensitive compounds).

Does the factory provide third-party test reports?

How to deal with quality issues?

We resolve quality issues via discounts, replacements, or re-production based on product assessment:

Immediate Action: Offer discounted pricing, expedited replacements, or batch re-manufacturing.
Documentation: Provide updated COAs and incident reports for customs/retailer compliance.
Prevention: Strengthen QC checkpoints (GMP/ISO 22000) to avoid recurrence.
Guarantee: Full traceability and liability coverage for seamless export operations.

MINIMUM ORDER QUANTITY(MOQ) AND DELIVERY TIME

What is the MOQ? Does it support small batch trial production?

How long does the production cycle from order to delivery take?

Should an NDA be signed to protect formula and brand information?

PRODUCT DEVELOPMENT AND PRODUCTION CAPABILITY

Do you support customized formula development? Do you have an independent R&D team or laboratory?

Is the source of raw materials transparent? Can COA be provided?

What dosage forms does the factory specialize in ?

Can you handle special process requirements?

COSTS AND COMMERCIAL TERMS

Is packaging design, label printing or shipping costs included?

Are there any hidden costs (mold fees, formula development fees)?

Our pricing is transparent, but let me highlight potential custom costs:

Formula Development: Charged separately if you require a unique formulation.
Mold Fees: Applicable for custom packaging (e.g., softgel shapes). Costs vary by design complexity but can be amortized over large orders.
Compliance Testing: Required for your target market (e.g., FDA lab fees).

We provide a detailed cost breakdown upfront and suggest bulk orders to optimize expenses. Shall we discuss specifics?

What is the down payment ratio and the final payment settlement method?

Do you cooperate with international logistics companies? Can you assist with customs clearance?

PACKAGING AND LABELING

Do you offer custom packaging designs?

Can it meet the needs of multi-language labels?

Does it support Halal certification?

FACTORY INSPECTION AND AUDIT

Do you accept third-party factory inspections or customer on-site audits?

Can you provide real-time feedback (photos, videos, inspection data) of the production process?