Strukmyer’s R&D division supports full lifecycle medical device development services and cosmetic product development, from early formulation and pilot-scale manufacturing to performance testing and regulatory readiness.
We specialize in developing and optimizing cosmetic formulations, advancing skincare formulation, adapting existing formulas, sourcing materials, and scaling processes for medical devices, OTC drugs, advanced wound care, and cosmetic science applications.
Our facilities support batch sizes up to 10 kg, with flexible packaging formats for prototype evaluation, including 1 mL syringes, single-dose packets, 4-oz tubes, jars, and 5-kg pails. We process solids, liquids, and colloidal systems – such as lotions, creams, and gels – across a wide viscosity range from 1 to 5,000,000 cps.
To ensure consistent, high-quality, and reproducible results, Strukmyer’s R&D team performs comprehensive analytical characterization, including:
pH analysis, Brookfield viscosity, conductivity, solubility, and specific gravity testing
Moisture content evaluation, titration, FTIR, and HPLC analysis
Custom analytical method development, verification, and validation to meet product and regulatory requirements
Our chemists develop specialized assays to support the medical device new product development process, including enzymatic degradation studies, FTIR structural characterization, fluid absorption capacity, and particle size analysis. For testing beyond our in-house capabilities, we collaborate with trusted external cosmetic laboratories and analytical partners.
To accelerate formulation reliability, Strukmyer conducts short-term stability screening such as accelerated and stressed studies, freeze–thaw testing, and environmental cycling. We also assess packaging compatibility and integrity to confirm long-term performance before advancing to real-time stability programs.
Strukmyer brings extensive experience navigating U.S. FDA regulations and global compendial standards, including USP, EP, and JP, while aligning with ASTM and ISO test methods. Our team has supported OTC drug commercialization, 510(k) submissions, and regulatory pathway development for new medical devices.
With more than 15 years of industry experience, integrated quality collaboration, and advanced scientific capabilities, Strukmyer provides customers with a strong foundation for successful product development, scale-up, and market launch.
Our Specialized Formulations
Strukmyer specializes in custom formulation development across skincare, pharmaceutical, and specialty applications. We work in tandem with partners to optimize ingredients, stability, and performance, delivering formulations designed for safety, success and customer satisfaction.
We provide comprehensive in-house stability testing, including packaging compatibility and degradation studies, to validate long-term product integrity, predicted shelf life, and consistent performance.
Our analytical capabilities include microscopy, pH and conductivity analysis, HPLC, FTIR, wet chemistry, endotoxin testing, and physical measurements such as density, viscosity, and gravimetric analysis. Moisture content is precisely measured using Karl Fischer titration to ensure formulation integrity.
Strukmyer develops and validates analytical methods in alignment with USP standards, supporting regulatory compliance, batch-to-batch consistency, and reliable product performance.
We provide technical support for OTC drug compliance, FDA documentation, and 510(k) medical device submissions, helping streamline regulatory pathways.
Our process expertise includes freeze-drying and vacuum drying solutions designed to preserve sensitive ingredients while maintaining stability, structure, and efficacy across pharmaceutical and cosmetic formulations.