Find Out More About How We Attend to Your Regulatory Needs

Meeting Customer's Requirements

Since 1988, B&H Consulting Services, Inc. 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. As a service company, we are committed to understanding and meeting each client’s objectives on an individual basis.

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Our Staff

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 U.S. 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.

Submission Services

  • Investigational New Drug Applications (IND) and Amendments

  • New Drug Applications (NDA) and Abbreviated New Drug Applications (ANDA)

  • Orphan Drug Designation Applications (ODD)

  • IND, NDA, DMF, and ODD Annual Reports

  • DSURs/PSURs

  • Drug Master Files and Amendments/Updates

  • Labeler Code Registrations

  • Drug Listings and Establishment Registrations

  • Structured Product Labeling (SPL)

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