Who we are...
At B&H, our technical staff provides unsurpassed attention to your
global regulatory needs. We provide seamless hands-on support to
your company, working off-site or on site at your facility.
B&H's technical team specializes in the preparation and assessment of
the Chemistry, Manufacturing and Controls (CMC) sections of global
submissions and is well versed in the format and content of the Common
Technical Dossier (CTD) and electronic CTD (eCTD).
B&H
utilizes docuBridgeŽ, a cost effective and compliant solution to the
global eCTD initiative, for dossier compilation and life-cycle
management. We maintain an account to FDA's electronic submission
gateway (ESG).
On behalf of our international clients, we
interact with FDA as their US Agent. As a result of our frequent
interaction with FDA, B&H specializes in the planning, organization and
conduct of successful Sponsor/FDA meetings.
B&H also has a team
of experts who focus on the preparation of IND and NDA annual reports to
meet the requirements of ICH eCTD/21 CFR.
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