Development & Manufacturing
Development & Manufacturing
API Development
Our development team, comprised of more than 150 scientists across four countries, exceeds expectations on even the most challenging projects. Through our Chemical Process R&D and Fermentation Development expertise, we efficiently advance programs from process design and optimization to scale-up and manufacturing. Working in state-of-the-art laboratories and supported by expert analysts, chemical engineers, fermentation scientists, and QA professionals, we develop scalable processes for preclinical, non-GMP, and GMP production.
API Manufacturing Services
Curia manufactures complex small molecule APIs at any scale through an integrated network of global facilities and specialized technologies. From advanced synthetic chemistry, flow chemistry, and fermentation to industrial chromatography and highly contained manufacturing environments, we support diverse development and commercial manufacturing needs, including sterile and high-potency APIs, controlled substances, steroids, and generics, while consistently delivering first-time quality manufacturing.
Regulatory Support
Curia’s decades of experience navigating the complex global regulatory landscape gives you a head start, and can help shorten your time to market. Our track record for quality is proven with through compliance with the main regulatory agencies like FDA, EMA, PMDA, CDE, Korean FDA, ANVISA…., and more than 550 API DMFs filed worldwide. Whatever your complex API manufacturing journey looks like, our regulatory team is here to help you succeed.
