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LBR Regulatory Services

Our Regulatory Affairs Professionals:

  • Have Extensive Experience Preparing Successful Regulatory Submissions
  • Have Experience Across A Variety of Therapeutic Areas
  • Can Help Clients Develop Optimal Regulatory Strategies
  • Stay Abreast of Evolving Regulatory Requirements
  • Can Serve As Liaison to the FDA
  • Perform Quality Assurance Auditing

LBR Regulatory Affairs professionals provide a full range of consulting services covering all stages of product development including preclinical, clinical and manufacturing as well as regulatory document writing, preparation and compilation pertaining to submissions, annual reports for INDs, NDAs, ANDA, BLAs, INADs, and NADAs. Our regulatory professionals are experts in their field and are authorized to represent the sponsor at meetings with the FDA.

LBR Regulatory professionals are experienced the development and maintenance of Trial Master Files, Orphan Drug application preparation and submission, eCTD preparation and conversion for all types of documents, package insert development, label development and review, and advertisement copy review.

Regulatory Successes

  • Wrote and submitted NADA for animal drug. Received FDA approval.
  • Managed and wrote preclinical and CMC sections for Acambis Smallpox Vaccine. Received FDA approval.
  • Wrote ISS and ISE sections for Bristol Myers HIV drug.
  • Managed and wrote NDA for oncology projects.
  • Wrote INDs for HIV vaccine, ovarian cancer drug, oncology drug, Army antidote drug, Lysteda, respiratory drug, and others.
  • Wrote fast track defense for Lysteda; FDA granted.
  • Writing eCTDs for cancer drug, four formulations.
Regulatory professionals meeting with FDA