Rely on Us To Attend to All of Your Regulatory Needs


B&H prides itself on the solid reputation that we have developed and maintained for over 30 years. Our company has grown slowly and steadily, 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 staff and experts.



B&H provides proven global regulatory strategy and critical document assessment, complete electronic submission capabilities to meet the global eCTD initiative, and CMC 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.

Meeting Customer's Requirements

Since 1988, B&H has supported hundreds of clients with diverse regulatory needs. Prior to beginning a project, we assess the company’s projects and requirements to gain an understanding of how B&H can most efficiently and effectively accomplish the tasks at hand and optimize team assignments. As a service company, we are committed to understanding and meeting each client’s objectives on an individual basis.

Our experts have extensive experience interacting with FDA on behalf of our clients. We 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 (CMC) sections for both U.S. and international submissions. B&H also has a department that focuses on preparing ICH eCTD/21 CFR compliant IND, DSUR, ODD, NDA and BLA annual reports and PADERs.

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.

More Statistics: Overview of Client Support

  • B&H manages more than 50 active clients as US or Regulatory Agent.

  • B&H has successfully prepared, submitted, and received approval for numerous NDAs, BLAs and ANDAs.

  • B&H has participated in defining strategy and has coordinated and participated or led more than 400 face to-face or teleconference meetings with FDA (~15 annually).

  • B&H successfully prepares and submits 8-12 INDs annually.

  • B&H prepares more than 175 annual reports annually.

  • B&H has successfully prepared, submitted, and obtained Fast Track, Breakthrough Therapy and Orphan Drug Designations, and negotiated and received Accelerated Approvals.

  • B&H has processes in place to ensure efficiencies in the lifecycle management of our clients’ applications.