End-to-end product development support for nutraceutical products
NUTRACEUTICALS
Concept & Market Research
We assist in identifying market opportunities, analyzing competitor landscapes, and defining product concepts aligned with FDA OTC categories and consumer trends.
Regulatory Pathway Assessment
We guide clients in selecting the appropriate regulatory route — OTC Monograph, 505(b)(2) NDA, or MoCRA Cosmetic — ensuring compliance from project initiation.
We provide formulation guidance, review lab data, and collaborate with contract development or manufacturing partners to optimize product performance and compliance.
Formulation Strategy
Analytical & Microbiological Testing
We help design analytical testing plans, select qualified laboratories, and review data to ensure product quality, safety, and regulatory acceptance.
Safety & Efficacy Evaluation
We support safety strategy development, clinical or consumer study design, and claim substantiation in collaboration with CROs and testing partners.
We coordinate with manufacturing partners to ensure smooth scale-up, process optimization, and adherence to QbD and cGMP principles.
Process Development & Scale-Up
Packaging Development
Functional packaging: Moisture/oxygen barriers, unit-dose formats, sustainable materials.
Compliance checks: Nutrition facts panel, supplement facts, allergen labeling.
Stability considerations: Light- and moisture-sensitive ingredients.
Clinical & Efficacy Validation
Clinical study design: Partnering with CROs for human trials (safety, efficacy).
In-vitro/in-vivo studies: Digestibility, absorption, pharmacokinetics.
Scientific substantiation: Building dossiers for marketing claims.
Brand positioning: Premium vs. mass-market strategy.
Storytelling & education: Science-backed marketing narratives.
Technical dossiers: Whitepapers and training decks for retailers.
Competitive mapping: Differentiation strategy for crowded categories.
Branding & Marketing Support
Nutraceutical Services
We offer Comprehensive solutions in formulation, product development, regulatory, QA/QC, and manufacturing.
Contact
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Support
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