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Post Approval - Labeling and Promotional Materials


BCI can assist in the development and/or review of labeling and promotional materials that are appropriately fair balanced and compliant with relevant regulatory guidelines. BCI’s consultants will help to ensure that labeling and promotional materials are scientifically accurate, clinically relevant, and in compliance with the guidelines of relevant Office of the Inspector General (OIG), FDA, Pharmaceutical Research Manufacturers Association (PhRMA), International Federation of Pharmaceutical Manufacturers Association (IFPMA), EMEA, PMDA, DCGI (India), Health Canada, TGA (Australia) and other countries.