601 N Mur-Len Road, Suite 9,
Olathe, Kansas, 66062, USA
Regulatory Services
We have more than 10 years of experience working the FDA throughout the pharmaceutical industries submitting PIND, INDs, ANDAs and NDAs. We carefully consider all strategies and alternatives during each step of regulatory process, helping you register products without costly delays.
Product Development Services
We have more than 10 years of experience developing generic (ANDAs) drug products as well as new (505(B)(2)) drug products. With our understanding of regulatory requirements, we consider all strategies and alternatives at each development phase, helping you develop a robust product at minimum cost.