Biologics Consulting Group, Inc. provides regulatory and product development advice to manufacturers of products regulated by CBER and CDER of the FDA. Our staff consists of experts in regulatory affairs product manufacturing and testing pharm/tox statistics and clinical trial design/evaluation.
Keywords: US Agent, foreign establishment, biologics manufacturers, Europe, Japan, Asia, Australia, compliance, guidelines, rule, 21 CFR 312.23(a)(1)(ix).
