Welcome to the BCG web site  We have tried to make it as informative and user friendly as possible. If you are seeking information about our capabilities start with the “About BCG” link and then review our “Services” and “Staff” pages. Note that BCG billing rates and consultant CVs are published on our web site because we think this information is valuable to potential clients seeking regulatory expertise.  We note that most of our competitors do not make this information publically available.  Maybe they are trying to hide something!  Many clients use our “Regulatory Library” to keep up with recent (and historic) FDA guidance documents and notices.  Also check out our “Newsletter Archive” and take time to sign up to receive our future newsletters.  BCG consultant attendance at future conferences, etc. is noted on the “Appearance” page.  Thanks for visiting the site.  Please click here to submit any suggestions about site improvement.

Biologics Consulting Group, Inc. specializes not only in the preparation and review of CBER regulatory applications (INDs and BLAs) as well as the inspection/audit of biologics manufacturing facilities but also in similar regulatory activities for drugs, devices and combination products. Because of our familiarity with FDA expectations we have an excellent reputation at the Agency for filing high-quality, easily reviewable applications.