Service Detail

🌟 OTC TOPICAL PRODUCT DEVELOPMENT

Monograph-Aligned • Compliance-Ready • Clinically Credible

We help brands, founders, manufacturers, and healthcare-driven innovators develop FDA-aligned OTC topical products with complete regulatory clarity and manufacturing-ready technical documentation. Every formula is engineered with safety, stability, and monograph compliance from day one—reducing reformulation cycles and ensuring faster, smoother launch readiness.

🎯 WHAT WE DO

End-to-End OTC Formulation & Regulatory Integration

From concept to commercialization, we build OTC products that meet 21 CFR monograph standards, support strong clinical claims, and pass manufacturing and audit requirements without friction.

Concept → OTC Pathway Selection → Formulation → Prototyping → Testing → Tech Transfer → Launch Tools

Ideal for:

• OTC brands & pharma-adjacent beauty companies
• OEM/ODM and contract manufacturers
• Medical skincare founders & derm-led brands
• R&D teams requiring compliant topical development

🔬 CORE EXPERTISE

Four Critical Domains That Drive OTC Success

• Regulatory-Aligned Formulation Strategy
  • Full alignment with 21 CFR OTC monographs
  • Active ingredient selection & concentration justification
  • Drug Facts box structure, labeling boundaries, warnings
  • Guidance for non-monograph / new drug pathways
  • MoCRA readiness: Safety substantiation, Responsible Person setup, AE reporting processes Your formula is built with regulatory logic baked in from day one.
• Advanced Topical Formulation Science
  • Active compatibility: buffers, neutralization, salt-out prevention
  • Solvent/co-solvent screening for complex actives
  • Occlusion control for dermatological performance
  • Vehicle creation: ✔ Gels ✔ Creams ✔ Lotions ✔ Hydroalcoholic systems ✔ Anhydrous sticks & sprays ✔ Film-forming systems Optimized for efficacy, sensory experience, and FDA expectations.
• Stress & Stability Engineering
  • Stability under pH shifts, ionic strength, temperature and light
  • Preservative system hardening for high-risk OTC matrices
  • Robustness testing to ensure product consistency in real-world conditions Designed to ensure long-term reliability, even with challenging actives.
• Technical Dossier & Launch-Ready Documentation
  • Prototype → Pilot batch development with QC specifications
  • Assay/potency verification via accredited partner labs
  • Claim support pathways: • SPF & broad-spectrum testing • Water resistance • Antiperspirant efficacy • Antimicrobial log-reduction (3rd-party)
  • Full technical file creation: Formula • Batch record • MBR/BI • COAs • Label copy • Artwork checks Your OTC product is manufacturing-ready and audit-ready.

🧪 TESTING & VALIDATION

Evidence, Compliance & Performance You Can Trust

Stability Testing

• Accelerated & real-time stability
• pH drift, viscosity, density
• Temperature cycling & phase robustness

Analytical Verification

• Active assay & potency testing
• Uniformity and degradation checks

Claim-Support Studies

• SPF & water-resistance testing
• Antiperspirant efficacy studies
• Antimicrobial log-reduction

All handled through vetted, compliant partner laboratories.

🤝 WHO WE WORK WITH

• OTC founders and medical skincare entrepreneurs
• Derm-backed brands and clinical product ranges
• Contract manufacturers & OEM/ODM partners
• R&D teams upgrading formulas for compliance
• Beauty brands expanding into OTC categories
• Labs needing compliant formulation collaboration

Built for both regulated market entries and global commercialization.

🚀 BUILD YOUR NEXT OTC INNOVATION WITH US

Partner with a formulation team that blends regulatory understanding, formulation science, and manufacturing intelligence into every stage of development.