Sample Projects

Since 1988, B&H Consulting Services, Inc. has supported many clients with diverse needs.  Prior to beginning a project, we assess the company’s needs and requirements 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 on an individual basis.

• Successfully managed 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, 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 approval

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• Established policies and procedures followed for the submission of over 110 IND and NDA Annual Reports each year.  For each annual report, activities included:
• 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

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• Coordinated and filed numerous initial Investigational New Drug (IND) applications
• Provided guidance to the sponsors 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 client internal requirements
• Volumized, paginated, and created overall Table of Contents for the INDs, and prepared the cover memo and FDA Form 1571 for inclusion in the submission

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• Working on-site at client 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 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 sponsor identified issues and questions
• 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 and filed documentation for state registrations, ensuring successful distribution of product

United States Agent

• Successfully represented international companies at meetings with FDA
• Coordinated activities and prepared background document submissions, i.e., “briefing packages” with questions for FDA consideration in advance of regulatory meetings
• Prepared, reviewed documentation and submitted initial IND Applications
• Prepared, reviewed and submitted subsequent amendments (CMC, clinical, pharmaco-toxicological), general correspondence, responses to requests for information, safety reports
• Prepared and coordinated meetings (pre-IND, end of phase 2, pre-NDA) between sponsor and FDA
• Assisted sponsors in regulatory strategy development and implementation
• Successfully filed Orphan Drug applications
• Submitted requests to FDA for fast track review
• Assisted in FDA negotiations on preclinical and clinical study requirements
• Compiled, reviewed and submitted drug master files and subsequent updates, as required
• Compile, review and submitted original New Drug Applications
• Coordinate activities to gain FDA approval of marketing applications

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Quality Control/Assurance

• Conducted GMP audits of contract manufacturing facilities in the US and abroad
• Established issuance/control system for Standard Operating Procedures (SOPs)
• Prepared quality-related SOPs and associated forms for a start up company
• Set up quality control program for release of drug product, including attributes inspection and testing  
• Conducted GMP training for quality and warehouse personnel

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