About us
At Cutyx, we take pride in our proven ability to deliver excellence in pharmaceutical development, setting the stage for innovation and success.
Boasting a cumulative experience of 28 years, our team stands as a testament to unwavering dedication in the pharmaceutical realm. Our journey includes significant stints in renowned pharmaceutical companies, focusing on global markets.
We specialize in the nuanced domains of formulation and analytical development, consistently steering projects from concept to commercial fruition.
Our proficiency extends to the specialized realm of transdermal patches, oral films, topical products and drug-device combinations. At the core of our capabilities is a mastery of In vitro permeation or release testing, handling extractables and leachables concerns, conducting comprehensive drug-device testing, and undertaking advanced characterization studies.
Our Vision
To become a global leader in revolutionizing pharmaceutical innovation, through our cutting-edge expertise.
Our Mission
To empower businesses with innovative transformative solutions in complex dosage forms, that drive sustainable growth.
Dr. Dhaval Pethani
Co-Founder and Chief Technology Officer
Dr. Dhaval Pethani is a highly accomplished Formulation Scientist with about 14 years of experience in research and development focused on Transdermal systems, ODF and Topical creams, ointments, gels, lotions, solutions, swabs; for the regulated markets.
Dhaval's extensive experience with complex drug delivery systems, including transdermal patches, films, and drug-device combination products, has consistently yielded successful outcomes across all phases of product development, from early-stage product development to commercialization.
Dhaval possesses comprehensive knowledge of cGMP requirements for transdermal and topical manufacturing facilities and has successfully navigated inspections of various regulatory Agencies. Dhaval is skilled also in new equipment design, Factory Acceptance Testing (FAT), machine qualifications, and related areas.
Dhaval earned his Doctorate in Pharmaceutical Sciences and a Master's degree in Pharmaceutics and Pharmaceutical Technology from L.M. College of Pharmacy, Ahmedabad, India.
Dr. Pradeep Dabhi
Co-Founder and Chief Scientific Officer
Dr. Pradeep Dabhi is an accomplished Analytical Development Scientist focused on Complex dosage forms, particularly Transdermal patches, Oral films, Intravaginal rings (IVR) & Topical products.
With about 14 years of experience in analytical development across the spectrum of complex dosage forms, Pradeep has played a pivotal role in numerous research and development endeavors, including ANDAs and NDA 505 (b)(2) projects related to Topical and Transdermal Drug Delivery Systems.
Pradeep has a strong background in analytical method development, qualification, validation, and transfer, as well as in-vitro release and skin permeation testing (IVRT/IVPT) alongwith statistical evaluations, extractables and leachables (E&L) and elemental impurities. In addition, Pradeep has extensive regulatory CMC knowledge, including both early and late-stage submissions, and responses to regulatory deficiencies.
Pradeep holds a Doctorate in Pharmaceutical Sciences and a Master’s degree, M.S.(Pharm.) from NIPER-Ahmedabad, India.
Our Expertise
Equipped with a profound comprehension of the strong principles of Chemistry, Manufacturing, and Controls (CMC), we have honed our expertise in various related domains. These include material selection and testing, formulation design, manufacturing process development & validation and analytical development. Additionally, we possess a thorough understanding of regulatory guidelines and work meticulously to ensure adherence to these requirements, guaranteeing the products meet all regulatory standards.
Product lifecycle experience
Cost-cutting keen eye
PAT prowess for swift manufacturing processes
Robust R&D and plant team networking
Rapid analysis, upping efficiency
Regulatory savvy in CMC requirements
Strategic supplier relationship (material and equipment)
Turnkey solutions for Product development
Dynamic duo of Formulation and Analytical development