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Regulatory Due Diligence

WR’s regulatory due diligence services can be tailored to the clients’ needs, which can range from development partnering to licensing to acquisition evaluations. Our solutions can help pharmaceutical and biotech companies, investment banks, legal firms, and consulting firms achieve efficiency by leaving due diligence to the experts and concentrating on other key assessments.

Areas of expertise include:

  • Overall development plans and regulatory strategy

  • Small molecule chemistry, manufacturing, and controls, including proposed changes to CMC

  • IND, NDA and BLA regulatory evaluation

Areas of specialty include:

  • Respiratory and nasal delivery products and delivery systems

  • Lung surfactants

  • Stability requirement evaluation

  • Extractables and leachables evaluation