Bio International Convention 2025

Flexible solutions for biotech companies at every value inflection point

At Certara, we offer specialized early development services designed to optimize this critical phase of drug development. Our approach combines cutting-edge science and modeling with extensive experience to provide you with a clear, strategic roadmap. From candidate selection and preclinical testing to early clinical trials, our goal is to streamline the process and address potential issues before they become major hurdles. 

Certara offers new and emerging biotechs a modern, data-driven approach to drug development. Starting with the end in mind, our cross-functional experts support your team to advance scientific insights, optimize resources, and de-risk your therapy development journey. 

Expertise for every modality: 

• Small molecules, biologics (monoclonal antibodies, ADCs) 
• Complex biologics (Bispecific Abs, siRNA, oligonucleotides, radiopharmaceuticals) 
• Cell and gene therapies, vaccines, drug-device combos, and devices 

Delivering comprehensive support for programs in late discovery and first-in-human studies (FIH): 

• Candidate selection, target product profile development & product development strategy 
• FIH enabling activity planning & stewardship 
• Pre-IND strategy, briefing document support, IND writing & submission 
• FIH execution & reporting 

Benefits of Our Solutions
By partnering with Certara, you gain access to a team of cross-functional experts who use advanced modeling and simulation techniques to predict drug behavior and outcomes. This helps in making informed decisions, reducing the risk of late-stage failures, and accelerating the time to market. Essentially, our services help you navigate the complexities of early development with confidence and access to the right expertise at the right time. 

How to Get Started
If you’re interested in learning more about how Certara can support your early development efforts, schedule a strategy session with us. During this session, we’ll discuss your specific needs and how our tailored solutions can align with your goals. Talk to one of our experts at Booth #9 to learn more! 

Additional Resources 

• Certara’s Strategic Early Development Solutions  
• “Where do I start?”: Strategies for selecting the first dose for human clinical trials 
• How the Simcyp Discovery Simulator will Accelerate Early Drug Development 
• Our Factsheet