Research Fields
Comprehensive
Expertise in Clinical
Research
First in Human
Our extensive experience and specialized knowledge ensures the highest levels of safety and precision in First in Human (FiH) trials. With a focus on minimizing risks and maximizing insights, we pave the way for successful clinical development and future trials.
Proof of Concept
We bring innovative ideas to life. Our Proof of Concept (PoC) research evaluates the initial clinical efficacy of new drugs, helping to identify promising candidates for further development. With a focus on precision and speed, we support your journey from concept to tangible therapeutic solutions.
DDI Studies
Drug-Drug Interaction (DDI) studies are crucial for understanding how new drugs interact with existing medications. Our DDI research focuses on identifying potential interactions that could affect drug efficacy or safety. By carefully evaluating these interactions, we help ensure that new therapies can be safely combined with other medications, minimizing the risk of adverse effects and optimizing patient outcomes.
DFI Studies
Drug-Food Interaction (DFI) studies are essential for understanding how food intake influences the absorption and efficacy of medications. Our expertise in DFI research helps identify how different foods or dietary patterns might alter drug behavior, which is critical for developing effective and safe treatment regimens. We provide detailed insights into these interactions, ensuring that new drugs are safe and effective regardless of dietary factors.
PK/PD and BABE Studies
Our expertise extends to complex PK/PD studies, where we analyze the relationship between drug concentration and its effects on the body. By conducting thorough Bioequivalence (BE) and Bioavailability (BA) studies, we provide crucial insights that guide the dosage and administration of new drugs, ensuring optimal therapeutic outcomes.
Cardiac Safety
Safety is paramount in drug development, and we lead the way in conducting Cardiac Safety assessments. Our advanced methodologies and state-of-the-art technology ensure the highest level of safety evaluation.
Vaccines
Our dedicated vaccine research focuses on developing and improving immunization strategies to combat infectious diseases. From early-phase studies to clinical trials, we provide comprehensive support in vaccine development. Our expertise ensures that new vaccines are safe, effective, and ready for widespread use, contributing to better public health outcomes.
Biosimilars
Biosimilars offer cost-effective alternatives to original biologic therapies. Our research in this area involves rigorous testing to ensure that biosimilars are highly similar to their reference products in terms of safety, efficacy, and quality. We support the development of biosimilars through comprehensive studies, helping to expand treatment options and improve patient access to essential therapies.
Generics and 505b2
Our work with Generics and 505(b)(2) applications focuses on bringing affordable and effective treatments to the market. Generics provide lower-cost alternatives to brand-name drugs, while 505(b)(2) applications allow for the approval of new drugs based on existing clinical data. We handle the complexities of these regulatory pathways to facilitate the development and approval of cost-effective medications, improving patient access and care.
Inhalation and Injection
We offer expertise in Inhalation and Injection studies, focusing on the unique challenges of these delivery methods. Whether developing inhaled medications or injectable therapies, our team provides the specialized knowledge and experience required to ensure successful outcomes in these complex areas of research.