United States / Regulatory Agent


B&H currently represents more than 40 international and US companies as their designated US/Regulatory Agent. We interact with FDA on our clients’ behalf and provide regulatory support.

 

Regulatory Affairs

  • Provide expert advice on regulatory strategy across all phases of development.
  • Critical review and/or preparation, technical writing, and assembly of:
  •    -  Investigational product applications
       -  Marketing submissions to Global Health Authorities
  • Handle day-to-day regulatory operations to assure compliance.
  • Liaise with Health Authorities to resolve issues and expedite drug development and marketing approvals.
  • Compile and review labeling including PLR format; collaboration with outside vendor for labeling conversion to SPL format.
  • Prepare/submit electronic Establishment Registrations/Renewals and Drug Product Listings (eDRLS).
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    Periodic and Annual Report Preparation


    B&H helps to assure that our clients are compliant with various regulations such as US 21 CFR 312.23 and 21 CFR 314.80 and 314.81, EU Clinical Trial Safety Reports, Annual Reports on the state of development of designated orphan medicinal products, and pharmacovigilance Periodic Safety Update Reports.

  • To prepare periodic and annual reports for submission to Regulatory Authorities, B&H tasks include:
  •    -  Issuance of the “Call for Information”
       -  Collection, review and verification of source data for accuracy and completness
       -  Preparation/circulation of draft report
       -  Revisions to the report, as necessary
       -  Preparation of the appropriate FDA form and cover letter
       -  Issuance of the final annual report and submission (paper or eCTD) to Health Authority(ies)

     

    Chemistry, Manufacturing & Controls

  • Critical review and/or preparation, technical writing, and assembly of:
  •    -  CMC sections for human and veterinary investigational and marketing applications filed to Global Health Authorities
       -  Documentation in support of generic drugs (ANDAs)
       -  Sterilization validation documentation for sterile products
       -  Drug Master Files and Veterinary Master Files
  • Prepare stability protocols and stability data tables for active pharmaceutical ingredients and drug products.
  • Write analytical methods and validation reports.
  • Respond to CMC-related submission queries from US and Global Health Authorities.
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    Electronic Submissions

  • Complete electronic submission capability to meet the global eCTD initiative. We utilize LORENZ docuBridge®.asp; a cost effective and compliant solution for electronic submissions.
  • The eCTDs published by B&H are reviewer friendly; we incorporate effective hyperlinks rather than excessive hyperlinks.
  • B&H maintains an account on FDA’s Electronic Submission Gateway (ESG) to provide our clients with worry-free delivery of electronic submissions to FDA.
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    Sponsor / FDA Meetings

  • B&H has coordinated and participated in more than 200 formal face-to-face and teleconference meetings with FDA.
  • Prepare meeting requests, background documents, and meeting minutes for Sponsor meetings with Health Authorities.
  • Conduct/lead rehearsals in preparation of or FDA/Sponsor Meetings.
  • Facilitate Sponsor Meetings with FDA.
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    Regulatory / Submission Life-cycle Management


    Prepare and submit initial eCTD INDs, NDAs, and ANDAs; maintain the electronic life-cycle of these applications.

     

    Worldwide Support


    B&H, in partnership with Voisin Consulting Life Sciences, can provide regulatory and submission support throughout Europe.