Regulatory Strategy/US Agent

Guided by our in-depth knowledge of the integrated drug development process, B&H can partner with or lead your regulatory efforts across a product's life-cycle at both the strategic and operational levels. B&H currently represents over 40 international companies as designated US / Regulatory Agent. We interact with FDA on our client’s behalf and provide regulatory affairs support.

Electronic Submission Support

B&H has complete electronic submission capabilities to meet the global eCTD initiative. We utilize docuBridge®.asp, a cost effective and compliant solution for electronic submissions. Our in-house experts have a proven track record with coordination, compilation, publishing and submission of initial eCTDs as well as supporting the eCTD lifecycle management. B&H has an approved WebTrader account and regularly sends submissions through the Agency’s Electronic Submission Gateway (ESG).

Briefing Documents and FDA Meetings

B&H has coordinated and participated in more than 200 formal face to face and teleconference meetings, as well as informal teleconferences with FDA. We facilitate meetings between Sponsors and FDA. We prepare meeting requests, background documents, and meeting minutes for Sponsor meetings with Health Authorities.

Chemistry, Manufacturing & Controls (CM&C) Technical Support

Successfully manage the coordination, technical writing and compilation of Chemistry, Manufacturing and Controls (CM&C) documentation for Drug Master Files and for both human and veterinary applications submitted to United States, Canadian and European Health Authorities, ensuring that all information is accurate, complete and meets currently acceptable standards, (i.e., ICH, 21 CFR, etc.).

How We Work

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.

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 US and international submissions. B&H also has as 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
  • Drug Master Files and Amendments/Updates
  • Labeler Code Registrations
  • Drug Listings and Establishment Registrations
  • Structured Product Labeling (SPL)