In the last few years, the pharmaceutical industry has invested in developing Complex Biologics including proteins, oligonucleotides, viral vectors, and engineered cells. One area within Complex Biologics experiencing tremendous growth is oligonucleotide therapies— nucleic acid polymers with the potential to...
We look at the growing regulatory trend of rolling NDA and BLA submissions to help accelerate FDA review, including benefits, challenges and risks.
How to set yourself up for a successful Health Canada PRCI submission
As seen on CNBC** Certara is the global leader in biosimulation, a powerful and proven technology. We transform traditional drug development by helping our customers create safe and effective medicines, faster. Certara (CERT) is proudly listed on Nasdaq.
Early HTA engagement ensures timely reimbursement and optimized market access strategies by aligning clinical evidence with HTA requirements.
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