About Us

B&H Consulting Services, Inc. prides ourself on the solid reputation that we have developed and maintained for over 25 years. Our company has grown slowly and steadfastly, one client at a time. We recognize the importance of each client’s goals and objectives and work closely with them to reach each milestone. We prepare quality documents, suitable for global filing to regulatory agencies. We have built our reputation by meeting established deadlines. We integrate ourselves within our clients' organizations such that we become an extension of the clients' technical staffs and experts.

Our Staff

Why choose B&H Consulting Services, Inc.?

B&H Consulting Services, Inc. provides proven global regulatory affairs, electronic submission and CM&C technical writing expertise to the health sciences industry. Founded in 1988, B&H’s professional team has strong scientific and business backgrounds and hands-on development experience. We focus on our clients’ specific needs to deliver seamless support throughout all phases of pre-marketing development and post-marketing activities. B&H specializes in the planning, organization and conduct of successful Sponsor/FDA meetings. B&H has complete electronic submission capabilities to meet the global eCTD initiative.

Who are we?

At B&H, our technical staff provides unsurpassed attention to your global regulatory needs. We provide seamless hands-on support, working off-site or on site at your facility.
The B&H team includes six (6) individuals who have Regulatory Affairs Certification (RAC). These experts are well versed in the format and content requirements for the Common Technical Document and electronic submissions. In addition, the team includes specialists who assess and/or prepare the Chemistry, Manufacturing & Controls sections for both US and international submissions. B&H also has a department that focuses on preparing ICH eCTD/ 21 CFR compliant IND, DSUR and NDA annual reports.
Our document management specialists are experienced in the preparation of eCTD compliant documents that meet current FDA/ICH submission requirements and are knowledgeable in the use of various Documentum-based systems and numerous word processing software programs.

B&H Consulting Services, Inc is a women owned business. We are certified with the Women's Business Enterprise National Council (WBENC).

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Voisin Consulting Life Sciences Acquires U.S.-based B&H Consulting Services, Inc., to Form One of the World’s Largest Independent Life Sciences Consulting Group.

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B&H submits approximately 500 regulatory submissions per year; this is an average of 2 submissions per day.

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More Statistics: Overview of Client Support

  • B&H manages more than 70 active clients and more than 40 clients as US / Regulatory Agent.
  • B&H has successfully prepared, submitted and received approval for numerous NDAs/BLAs and ANDAs in CTD format or as eCTD submissions.
  • B&H has participated in defining strategy and has coordinated and participated in more than 200 face to face or teleconference meetings with FDA.
  • B&H successfully prepares and submits 8-12 INDs annually.
  • B&H prepares more than 175 Annual Reports annually.
  • B&H has successfully prepared and submitted 25+ initial eCTD INDs and NDAs and maintains the electronic life-cycle management of these applications.