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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
most efficiently and effectively accomplish the task at hand.
As a service company, we are committed to understanding
and meeting each client’s needs on an individual basis.
The following are just a few examples of projects completed by
B&H.
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Electronic Submissions
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Coordination, compilation, publishing, validation and
submission of numerous electronic dossiers, which have been
accepted by FDA
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Collaboration with EU partner on successful compilation,
publishing, validation and submission of eCTD dossiers in
the US and EU on parallel timelines
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Support the lifecycle management of eCTD projects for
investigational and marketing applications
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Preparation and submission of electronic labeler code
requests, establishment registrations and drug listings,
ensuring successful product distribution
Global
Regulatory Affairs Support
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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.
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Represented non-US companies as United States Agent to FDA
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Compiled and filed information and protocol amendments,
safety reports, annual reports and general correspondence to
ensure compliance with all FDA regulations
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Acted as liaison with FDA on behalf of client and provided
regulatory strategies for sponsor identified issues and
questions
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Assisted with drafting Core Data sheets, USPI and SmPCs
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Assisted clients through the Mutual Recognition Procedure
(MRP)
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Requested meetings with FDA; prepared “Briefing Packages”
submitted to FDA in advance of meetings
Chemistry
Manufacturing & Controls (CM&C) Technical Support
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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.)
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Worked with CMC teams to compile amendments, supplements and
variations to global regulatory submissions
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Contracted and monitored analytical methods development
studies on behalf of client companies
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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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United States Agent
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Successfully represented international companies at meetings
with FDA
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Coordinated activities and prepared background document
submissions, i.e., “briefing packages” with questions for
FDA consideration in advance of regulatory meetings
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Prepared, reviewed documentation and submitted initial IND
Applications
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Prepared, reviewed and submitted subsequent amendments (CMC,
clinical, pharmaco-toxicological), general correspondence,
responses to requests for information, safety reports
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Prepared and coordinated meetings (pre-IND, end of phase 2,
pre-NDA) between sponsor and FDA
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Assisted sponsors in regulatory strategy development and
implementation
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Successfully filed Orphan Drug applications
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Submitted requests to FDA for fast track review
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Assisted in FDA negotiations on preclinical and clinical
study requirements
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Compiled, reviewed and submitted drug master files and
subsequent updates, as required
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Compiled, review and submitted original New Drug
Applications
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Coordinated activities to gain FDA approval of marketing
applications
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Annual Reports for INDs and NDAs
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Established policies and procedures followed for the
submission of more than 100 IND and NDA Annual Reports each
year. For each
annual report, activities included:
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issuance of the “Call for Information”
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collection, review and verification of source data for
accuracy and completeness
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preparation and circulation of a draft report for
comments and approval
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revisions to the annual report, as necessary
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preparation of the appropriate FDA form and cover letter
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issuance of the final annual report, FDA form and cover
letter for final review and signature prior to FDA
submission and internal distribution
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Initial
Filing of INDs
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Coordinated and filed numerous initial Investigational New
Drug (IND) applications (paper)
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Successfully filed many electronic INDs
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Provided guidance to the sponsors on the content and format
of the initial applications
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Reviewed source documents to ensure all items of the IND
were accurate and complete, meeting requirements of 21CFR
312.23
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Prepared and collated documents to meet FDA’s requirements,
as well as B&H standards and the client internal
requirements
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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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