Our R&D Services
ProTopical Solutions provides formulation development expertise of new and existing topical semi-solid products. We specialize in creams, gels, ointments, lotions, solutions, sticks, sprays, and foams. If you have a new idea for a Pharmaceutical, OTC, or cosmetic product, ProTopical can help tailor your new product, or product line, to the treatment of the desired indication. ProTopical can also help with existing products that may show signs of phase separation, non-uniformity, difficulty in manufacturing, and stability issues.
Rx Formulation Development
We are experts in NDA, ANDA, and 505B2 formulation development of topical products. From initial solubility studies of IID listed ingredients, through prototype formulations for IVPT studies, and Phase I clinical supplies.
Cosmetic Formulation Development
We specialize in the development of all topical formulations with a strong emphasis on understanding the skin physiology and condition for topical treatment.
NDA, ANDA, 505B2, and IMPD Regulatory Documentation.
With a combined over 50 years of FDA filing experience, and 38 Rx approvals, let us help with your document preparation and FDA submission.
OTC Formulation Development
With over 20 years of drug product formulation development, we can help you develop new product ideas that ensure API potency, homogeneity, and chemical stability.
Formulation and Process Evaluation of Existing Products
We can evaluate and make suggestions for your current topical products from phase separation, content uniformity, to processing and filing issues.
Patents
Patent expertise in protecting your new NDA, OTC, and Cosmetic product, and extensive experience in Paragraph IV ANDA development.