Regulatory Gap Analysis

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A gap analysis is a powerful tool that can be used to forecast a product’s success. It involves a logical and scientific review of available information and forms the basis for preliminary discussions with regulatory agencies. BLA Regulatory aims to provide an unbiased analysis in an expert and cost-effective manner to assure our clients do not start making changes that are not necessary or not appropriate. Our systematic strategic planning improves the success and progress of potential products by assessment of:

  • Background information
  • Product name and chemical nature
  • Indication (disease intended to treat)
  • Animal or in vitro experiments carried out to date
  • Manufacturing details (GMP or non-GMP)
  • Prior human experience (prior marketing details, adverse experiences, historic data)
  • Product’s Strengths, Weaknesses, Opportunities, and Threats