BioStem Technologies Inc., a pre-clinical-stage biotechnology company focused on elements of perinatal tissue for use in regenerative therapies; announced that it has engaged Biologics Consulting, a full-service regulatory and product development consulting firm for biologics, pharmaceuticals and medical devices, to help facilitate the progression of investigational new drug (IND) candidates through the regulatory pipeline.
In the nearly three decades since its founding, Biologics Consulting has built an unprecedented record of achievement, assisting clients all over the globe to address nonclinical, clinical, product development, and regulatory compliance challenges. Biologics Consulting has served more than 3,500 companies in 53 countries, and in the past four years, it has contributed to more than 50 original INDs, 75 BLAs/NDAs (full and supported), 80 510Ks, and 42 IDEs.
Biologics Consulting will help BioStem navigate through the FDA’s Biologics License Application (BLA) process. Biologics Consulting will provide education and support, best practices, and assist with the necessary communications with the relevant regulatory agency groups.
Jason Matuszewski, CEO of BioStem Technologies, states, "We are excited to announce our engagement of Biologics Consulting. Based on their extensive experience in Medical Device and BLA regulatory navigation, they are a perfect strategic partner to help navigate our Local Microenvironment Activation based product candidates through the FDA filing and approval processes."
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