Sample Projects

Over the years, B&H Consulting Services, Inc. has supported many clients with diverse needs.  Prior to beginning a project, we assess a company’s needs to gain an understanding of how B&H can best help accomplish the task at hand.  As a service company, we are committed to understanding and meeting each client’s needs.

The following are just a few examples of projects completed by B&H

• Manage the coordination, technical writing and compilation of Chemistry, Manufacturing and Controls (CMC) documentation for both human and veterinary applications submitted to United States, Canadian and European Health Authorities investigation al and marketing applcations, ensuring that all information was accurate and complete, meeting currently acceptable standards, (i.e., ICH, 21 CFR, etc.)
• Worked with CMC teams to compile amendments, supplements and variations to global regulatory submissions
• Contracted and monitored analytical methods development studies on behalf of client companies

• Addressed Chemistry, Manufacturing and Controls (CMC) queries from Health Authorities around the world
• Drafted responses and forwarded to CMC team for review and approval
• Worked with company affiliates to successfully submit timely responses to queries, resulting in marketing approvals

• Established policies and procedures for the submission of over 110 IND and NDA Annual Reports each year.  For each annual report, activities include
  • issuance of the “Call for Information”
  • collection, review and verification of source data for accuracy
  • preparation and circulation of a draft report for comments and approval
  • revisions to the annual report as necessary
  • preparation of the appropriate FDA form and cover letter
  • issuance of the final annual report, FDA form and cover letter for final review and signature for FDA submission and internal distribution

• Filed initial Investigational New Drug (IND) applications
• Provided guidance on the content and format of the initial applications
• Reviewed source documents to ensure all items of the IND were accurate and complete, meeting requirements of 21CFR 312.23
• Prepared and collated documents to meet FDA’s requirements, as well as B&H standards and the clients’ internal requirements
• Volumized, paginated, and created an overall Table of Contents for the IND, and prepared the cover memo and FDA Form 1571 for inclusion in the submission

• Worked on-site at clients’ locations; reviewed and compiled documentation for submissions, prepared cover letters and corresponding required FDA forms; coordinated all activities related to photocopying, pagination and submission.

• Represented non-US companies as United States Agent to FDA
• Compiled and filed all information and protocol amendments, safety reports, annual reports and general correspondence to ensure compliance with all FDA regulations
• Acted as liaison with FDA on behalf of client and provided regulatory strategies for issues and questions that arose
• Assisted with drafting core data sheets, USPI and SmPCs
• Assisted clients through the Mutual Recognition Procedure (MRP)
• Requested meetings with FDA; prepared “Briefing Packages” submitted to FDA in advance of meetings.

• Submitted applications for assignment of a Labeler Code for a new private label distributor
• Prepared the necessary forms for registration of Drug Establishment (Form FDA 2656) and Drug Product Listings (Form FDA 2657)
• Interacted with FDA to ensure submission of accurate documentation
• Completed state registrations, ensuring successful distribution of product