With decades of experience in generic drug testing and bioequivalency, our talented and dedicated scientists are uniquely qualified to formulate improved, novel, national brand equivalent (NBE), over the counter (OTC), cosmeceutical and personal care products, including dermatological and medicated topical treatments, lotions and creams, and OTC personal care products, such as sunscreens, in addition to providing indispensable analytical support.
Element’s end-to-end product testing and development services support the entire product development life cycle for over the counter, cosmeceutical and personal care products. Our dedicated, knowledgeable and consultative teams have extensive experience in safety and performance testing, including compendial, monograph and pharmacopeial testing for OTC products, shelf life and stability testing, product failure and impurity testing, reformulation, formulation, deformulation, and innovative product development. With an in-depth understanding of ever-evolving regulatory and consumer landscapes, including industry trends, and changing regulations, Element consistently delivers industry-leading projects tailored to meet your specific needs.
Our expert formulation and development scientists keep up to date with all regulatory requirements to ensure products meet evolving standards. Element has extensive experience in safety and regulatory testing, including developing, validating, optimizing and verifying methods for releasing nonprescription (over the counter) drug products and personal care products that are regulated by the FDA’s Over-the-Counter Final Monograph for Skin Protectant Drug Products guidance. Our team has deep experience and expertise successfully developing and validating analytical methods as well as releasing products with complex matrices and active ingredients, including those that contain colloidal oatmeal and other skin protectants. Expedite speed-to-market and ensure the safety, quality and efficacy of your OTC topical products, cosmeceuticals and personal care products with Element’s comprehensive product development and testing services.
OTC, cosmeceutical and personal care product development and testing services
- Compendial and monograph testing
- Method verification
- Method development, validation, optimization and transfer
- Stability programs and shelf-life studies
- Contaminant identification
- Raw material selection and verification
- Failure analysis
- Deformulation and product reverse engineering
- Product innovation, formulation and process development
- Product reformulation
- Scale-up and manufacturing support
- Product performance testing
- Packaging selection and compatibility testing
- Cosmeceutical safety testing
- Cosmeceutical product screening (emulsifiers, preservatives, formaldehyde, synthetic fragrances, impurities and contaminants)
- Intellectual property and litigation support
The Element advantage
With a proven history of success solving complex technical challenges in existing formulations and developing new innovative formulations through product research, testing and development services, Element’s team of engaged scientific and industry experts have the expertise, know-how and state-of-the-art technology needed to meet your needs and exceed your expectations. Achieve your goals with Element’s fully customizable, comprehensive programs incorporate the assays, methods and advanced instrumentation tailored to address the regulatory and industry expectations of your end-market, securing your competitive advantage in the OTC, cosmeceutical and personal care product space.
To learn more about our over the counter, cosmeceutical and personal product development and testing services, or to speak with one of our experts, contact us today.
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ICH, USP, EP, BP and JP monograph tests of raw material, drug substance/product, starting material, cell banks, vectors, bulk harvest and control cells.
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Element offers advanced pharmaceutical stability testing and ICH storage services to ensure the maintenance of product quality, safety and efficiency throughout the shelf life.
Element's leading product development labs have a track record of success innovating, optimizing and formulating products for various industries and applications.
Element’s expert chemists have successfully reverse engineered hundreds of formulations for a huge array of products and provided detailed information on the identity and quantity of ingredients.