When developing over-the-counter (OTC) products, the stakes are significantly higher. OTC formulations for issues like acne, eczema, or SPF protection must adhere strictly to FDA guidelines.
Sentara Labs provides full-spectrum clinical compounding and manufacturing solutions designed specifically for OTC products. Navigating these requirements demands a structured workflow:
1. Consultation & Brief: Defining the active ingredients and permitted label claims.
2. Formula Development: Iterating on the formula using clinically validated actives.
3. Stability Testing: Conducting accelerated and real-time stability studies to guarantee product safety and shelf life.
4. Quality Assurance: Multi-stage in-process testing against international safety standards.
With our FDA registered facility, brands can trust us to deliver safe, effective, and compliant OTC personal care products.