Our regulatory team completes over 150 agency submissions each year, supporting all stages of the product lifecycle. We assign a dedicated regulatory professional to each of our clients and work directly with our manufacturing facilities to provide turn-key solutions.
Efficient, comprehensive transitions from early phase (preclinical up to phase 1) to late phase (phase 2 and beyond) are critical to the…
Clinical manufacturing, an important step in the pharmaceutical world, plays a vital role in bringing new drugs to market. While the term…
Streamline your clinical trials with ease using our top-tier blinding services. Effortlessly manage clinical supplies, minimize errors, and guarantee confidentiality. Boost your…
“New drugs receiving expedited approval have shorter timelines, which can create unique challenges for development and manufacturing. Joe Dukich, director of operations…
Abstract: This case study provides a deep dive into Hycon’s achievement in developing a multi-API (Active Pharmaceutical Ingredient) fixed-dose combination oral drug,…