We help health-focused innovators clearly differentiate between drug, dietary supplement, and functional food pathways—and then execute the fastest, most compliant route to market
We help health-focused innovators clearly differentiate between drug, dietary supplement, and functional food pathways—and then execute the fastest, most compliant route to market. From early formulation choices to full regulatory submission and commercialization, our team stands beside you.
1) Regulatory Pathway Mapping
Clarify whether your product should be positioned as a drug, supplement, or functional food, and define the evidence, claims, and approvals required for each path.
2) Formulation & Evidence Strategy
Design science-backed formulations (actives, doses, delivery forms) and build the evidence package (non-clinical, clinical, or functional claims) aligned with your target label and market.
3) Dossier & Documentation Development
Prepare and structure technical files (quality, safety, efficacy), label and claim justifications, risk assessments, and market-entry documentation.
4) Quality, Safety & Compliance
Implement GMP/GHP/HACCP-aligned systems, stability studies, specifications, and post-market surveillance plans tailored to the regulatory class of your product.
5) Market Access & Export Readiness
Translate regulatory and labeling requirements across target geographies, design localization strategies, and support registration, launch, and scale-up.
6) Innovation & Acceleration Services
As a health accelerator, we connect you with specialized labs, pilot-scale production, clinical partners, and investors to de-risk and speed up development.
Diagnosis & Gap Analysis – Define product class, claims, and regulatory gaps.
Roadmap & Timelines – Build a realistic, budgeted plan (regulatory, R&D, market access).
Execution – Formulation, documentation, compliance setup, and submission.
Launch & Scale – Post-market monitoring, export strategy, lifecycle optimization.
End-to-end clarity on classification (drug vs supplement vs functional food)
Cross-functional expertise (regulatory, R&D, quality, commercialization)
Accelerator infrastructure to shorten time-to-market
Regional & international regulatory familiarity
Startups and SMEs in health, nutrition, and herbal medicines
R&D teams seeking a compliant go-to-market path
Companies planning cross-border expansion of health products
To receive consultation, please fill out the form below. Our experts will contact you as soon as possible.
