Regulatory Strategy/US AgentGuided 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 SupportB&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 MeetingsB&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 SupportSuccessfully 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.).
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 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.
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)