● GCP, GMP & GCLP, ICH and HIPAA compliant.
● Pharmaceutical regulatory experience with FDA therapeutic applications including; IND, NDA, BLA, ANDA, OTC, BLA.
● Medical Device regulatory application expertise, including; 510(k), PMA, DeNovo, HDE, OTC, 513(g), IDE.
● Electronic data security compliant with NIST and GDPR standards.