BioPharm CMC Advisers, LLC brings decades of experience in developing small and large molecules from late discovery phase to product approval (BLA/NDA).  The expertise gained from working on variety of modalities – monoclonal antibodies, multi-specifics, ADC, oligonucleotides, mRNA, DNA, peptides, proteins, small molecules - practical knowledge from having been involved with >100 IND/IMPD filing, multiple regulatory interactions/meeting and addressing issues pre-emptively will help start-up and mid-size companies to take products into clinic and beyond. 

Recently released complete response letter (CRL) by FDA suggest that many biotech companies fail to pay attention to the CMC resulting in clinical hold, delays, or even lack of approval.  The data suggests that 74% of these CRL had CMC issues, compared to only 35% related to clinical or safety issues.  Hence, a well thought, proactive CMC plan often saves both time and dollars.  BioPharm CMC Advisers can be your support for your CMC success!