Customizable, stability-tested nutraceutical gummies and supplements manufactured under Health Canada Site License and US FDA Registration.
Integrated product formulation, regulatory filings, and quality verification under one validated quality management system.
Operating under Health Canada Site Licences, US FDA Facility Registration, and strict cGMP standards. Full audit-ready documentation provided for global customs.
Every lot is tested using HPLC (potency), ICP-MS (heavy metals), and GC-MS (purity/solvents). Retained samples are held for full shelf life to assure consistency.
Pilot batches starting at 1,000 units for capsules/tablets and 5,000 units for customized gummies, allowing brands to test market demand before container scaling.
In-house preparation of Health Canada NPN submissions, FDA Supplement Facts panels, EU food supplement notifications, and GCC/UAE registration dossiers.
Strategic production networks across Canada, United States, China, India, and UAE to optimize tariff exposure, raw material sourcing, and regional lead times.
Dedicated production lines for Vegan (HPMC & Pectin), Allergen-Free, Organic, Halal, and Kosher qualifying formulations with validated clean-in-place (CIP) protocols.
The global dietary supplement market is experiencing a profound paradigm shift. Driven by algorithmic search personalization and consumer demand for verifiable efficacy, procurement managers can no longer rely on standardized off-the-shelf formulas. Modern contract manufacturing demands high Information Gain—leveraging advanced biochemical bioavailability, stability preservation, and stringent global regulatory compliance.
Gelatin-based gummies traditionally dominated the market due to their elastic texture and low raw-material cost. However, high-temperature degradation and consumer migration toward plant-based diets have propelled Citrus Pectin to the forefront of OEM contract manufacturing. Pectin features a higher thermal melting point (over 60°C / 140°F), preventing product agglomeration during trans-equatorial maritime shipping.
Formulating with pectin requires precise brix control (68°–72° Brix) and tight pH monitoring (3.2–3.5 pH) during the cooking phase to achieve optimal gelation without inactivating heat-sensitive bio-actives like Vitamin C or Methylcobalamin.
Consumer intent mining reveals a massive surge in searches for "MTHFR gene compatibility." Standard folic acid and cyanocobalamin are increasingly rejected by informed buyers due to conversion bottlenecks in individuals with MTHFR enzymatic polymorphisms. Leading OEM contracts now specify L-5-Methyltetrahydrofolate (5-MTHF) and Methylcobalamin (Active B12) paired with Trimethylglycine (TMG) and CoQ10. This direct-donor pathway bypasses hepatic conversion, offering superior cellular absorption and supporting cardiovascular methylation.
Traditional probiotic strains (such as Lactobacillus and Bifidobacterium) suffer rapid CFU loss when exposed to the moisture and ambient heat involved in gummy candy manufacturing. The industry shift focuses heavily on spore-forming organisms like Bacillus Coagulans. Encased in a natural protective endospore structure, these strains survive acidic gummy deposition temperatures and gastric acid passage, reaching the small intestine with >95% viability without expensive refrigerated cold-chain logistics.
Below is the analytical testing specification executed by Q Nutritions' laboratory quality control team for commercial lot release:
| Analytical Parameter | Testing Methodology | Acceptance Criterion / Specification Limit | Regulatory Impact |
|---|---|---|---|
| Heavy Metals (Pb, Cd, Hg, As) | ICP-MS (Inductively Coupled Plasma) | Lead < 0.5 ppm, Cadmium < 0.3 ppm, Mercury < 0.1 ppm | USP <2232> & Health Canada Compliance |
| Active Assay Potency | HPLC / UV-Vis Spectrophotometry | 90.0% – 120.0% of Labeled Target (Overage Guard) | FDA 21 CFR Part 111 Potency Guarantee |
| Microbial Enumeration | USP <2021> / <2022> Plating | Total Plate Count < 1,000 CFU/g, Yeast/Mold < 100 CFU/g | Pathogen Negative (E. coli, Salmonella, S. aureus) |
| Thermal Stability & Water Activity | Chilled Mirror Dew Point (Aw) | Water Activity (Aw) < 0.62 at 25°C | Prevents Microbial Growth & Gummy Melting |
| Disintegration / Dissolution | USP <701> Disintegration Apparatus | Complete breakdown within < 45 minutes | Optimized In-Vivo Gastrointestinal Bioavailability |
Technical clarity on minimum order quantities, lead times, regulatory filings, and custom manufacturing capability.
Our minimum order quantities are structured to accommodate emerging DTC brands as well as enterprise pharmacy chains. Private Label stock formulas begin at 1,000 bottles for encapsulated powders, softgels, and tablets. For fully custom formulations (including unique pectin gummy molds, specialized flavors, and novel active combinations), MOQs start at 5,000 units (or 500 kg for bulk powder blends). Pilot batch options are available for stability testing and regulatory filing validation.
Standard Private Label turnaround is approximately 6 to 8 weeks upon label artwork finalization. Fully custom OEM contract development—which encompasses custom R&D formulation, raw material identity verification, pilot batching, analytical testing, and stability benching—takes between 8 to 12 weeks. We provide weekly milestone tracking via a dedicated account project manager to ensure your retail launch date remains secure.
Our regulatory affairs department prepares comprehensive compliance documentation tailored to your target jurisdiction. This includes Natural Product Number (NPN) submissions for Health Canada, US FDA Supplement Facts panel structuring, European Union food supplement notifications, and Middle Eastern GCC registration files. Every shipment includes a Certificate of Analysis (COA), Certificate of Free Sale, and Certificate of Origin.
Yes. Our facility operates dedicated, segregated processing suites with validated cleaning-in-place (CIP) protocols to prevent cross-contamination. We specialize in sugar-free pectin gummies (utilizing erythritol, xylitol, or allulose), vegan HPMC capsule shells, gluten-free, dairy-free, and soy-free powder matrixes, alongside certified Halal and Kosher product lines.
We enforce a strict 100% raw material testing policy. Incoming actives and botanicals undergo Fourier Transform Infrared Spectroscopy (FTIR) or HPLC testing for identity. Finished products are evaluated using ICP-MS for heavy metals, GC-MS for residual solvents, and USP-standard plating for microbial safety. Independent third-party ISO 17025 accredited laboratory confirmations are appended to every commercial batch release.
Custom formulations developed specifically under your paid contract brief and master service agreement remain 100% your proprietary Intellectual Property (IP). Mutual Non-Disclosure Agreements (NDAs) are executed prior to sharing technical briefs or proprietary active ratios.
From initial discovery to destination customs clearance, our standardized operational gates ensure zero margin risk.
