Health Canada released guidance on March 12, 2019 pertaining to its Public Release of Clinical Information (PRCI) initiative. Health Canada’s objective with this initiative is to make anonymized clinical information in drug submissions and medical device applications publicly available for...
Do expensive bioequivalence studies stall your generic drug approval? Learn how you can streamline complex generic drug development with our white paper.
China is the second largest pharmaceutical market in the world. Demand is likely to increase as the government introduces reforms to improve the country’s health care system. These changes are helping multinational drug makers tap into the Chinese pharmaceutical market....
Nirpal Virdee, Synchrogenix’s Global Head of Transparency and Disclosure recently sat down with Trishna Bharadia, award-winning health advocate and patient engagement champion, for a discussion around patient engagement and patient centricity. Their discussion was moderated by Darshan Kulkarni of the...
Pediatric PBPK models have broad application in the drug development process and are being used increasingly to optimise and replace clinical studies. However, the approach has yet to become fully integrated in regulatory submissions. Emerging data support an expanded integration...
There are common themes driving how quickly you can get from your last database lock (DBL) to submission of your marketing application. Speaking from first-hand experience across more than 50 marketing submissions, Synchrogenix regulatory science experts will demonstrate how, through...
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...
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...
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.
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