Canonical: https://gummywise.com/en/quality-and-regulatory Language: en Last modified: 2026-09-25 QUALITY BY DESIGN # Make quality a design input, not a final test. A practical control strategy that puts critical quality attributes ahead of formulation, process, packaging and supplier decisions. [Tell us about your project]() [How do we work?]() ![Laboratory samples and formulation ingredients for gummy quality evaluation]() QUALITY BY DESIGN SCOPE ## See technical decisions in one system. Moisture transfer, sticking, active loss, microbial risk and packaging performance are interconnected in gummy products. A quality plan makes these relationships traceable throughout development. WHO IS IT FOR? - Teams preparing new product specifications - Brands facing stability or packaging problems - Companies standardizing supplier quality requirements DELIVERABLES ## Deliverables your team can use Every engagement produces concrete technical outputs that support the next decision, trial or procurement step. 01 ### Critical quality attributes A framework for appearance, weight, texture, pH, solids, water activity, active content and microbiology. 02 ### Control plan Sampling, frequency, method and acceptance logic from raw-material receipt to finished product. 03 ### Stability protocol Definition of conditions, time points, test panel and packaging variants. 04 ### Technical file review A consistency review of formulation, process, specification and label inputs. IMPLEMENTATION ## Four decision gates The scope may be narrowed to match the project stage, while the decision logic always remains traceable. 1. 01 ### Map product risks 2. 02 ### Draft CQAs and specifications 3. 03 ### Build control and stability plans 4. 04 ### Trend results and manage changes “A good result comes from designing the formula and process—and the process and equipment—toward the same target.” THE GUMMYWISE APPROACH ![Laboratory samples and formulation ingredients for gummy quality evaluation]() FREQUENTLY ASKED QUESTIONS ## Quality and Regulatory Design 01 **Do you provide final regulatory approval?** No. Gummywise identifies risks and requirements from a technical-development perspective; formal compliance must be confirmed with authorized experts and authorities in the relevant market. 02 **Is shelf life determined only by active-ingredient testing?** No. Sensory change, texture, moisture, water activity, microbiology and packaging performance should be evaluated alongside active content. 03 **Can packaging selection be included?** Yes. Packaging requirements can be defined according to moisture and oxygen sensitivity, use pattern, logistics and target shelf life. RELATED SERVICES ## Other parts of the same system [PRODUCT DEVELOPMENT ### Gummy R&D and Product Development Gummy R&D consulting that turns a product idea into technical requirements, a prototype plan, a process window and structured scale-up steps. ]()[VITAMINS & MINERALS ### Vitamin Gummy Formulation Technical consulting for vitamin gummy formulation focused on active compatibility, process loss, taste masking, serving design and stability. ]()[FUNCTIONAL PRODUCTS ### Supplement Gummy Development Product and process development support for supplement gummies containing collagen, botanical extracts, probiotics and other functional ingredients. ]() YOUR PROJECT ## Let's reduce technical uncertainty together. Share your product idea, current stage and the problem you want to solve. We will establish the right project framework in the first discussion. [Send project brief]() YOUR PROJECT ## Tell us about your project Share your product idea, current stage and the problem you want to solve. We will establish the right project framework in the first discussion. [DIRECT EMAIL**ufuk@brix.tr**]() PROJECT BRIEF / EN**Tell us about your project** [ufuk@brix.tr]()