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Peptides & Oligonucleotides
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Regulatory challenges and strategies for oligonucleotide, peptide and mRNA therapeutics - WHITEPAPER

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In the last decade, the costs for developing new medicines has more than doubled. The patient-centric drug considerations and health care demands, pressure the industry to speed up global access to treatments with associated costs. As such, regulations and policy also need to evolve rapidly, so that innovation is not slowed down by bureaucratic obstacles, which could endanger getting and maintaining licenses worldwide.

This whitepaper explores methods in which pharmaceutical companies can navigate the current regulatory frameworks around peptide, oligonucleotide and mRNA therapeutics, including:

  • Case studies of successful approvals in the US and EU

  • The current classifications for mRNA therapeutics

  • Complexities behind regulations for oligonucleotides and peptides


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