Biopharma Consulting

Services

Nonclinical Drug Development:

  • Nonclinical development strategy and programme design, small-molecule and biotech
  • Review and interpretation of nonclinical study data, including gap analysis
  • Nonclinical safety evaluations, benefit-risk assessments and problem-solving
  • Preparation/review of nonclinical overviews, white papers and other regulatory documents
  • Preparation/review of responses to nonclinical regulatory questions/deficiency letters
  • Liaison with regulatory agencies
  • Due diligence for acquisitions and legal disputes
Specialist Consulting:
  • Impurity qualification, preemptive and/or in response to Agency or EDQM questions: API related substances, PhEur/USP, solvents, metal ions
  • Assessment of routes of synthesis for potentially mutagenic impurities in drug substances
  • Mutagenic impurity safety assessments
  • Safety assessment of excipients (such as preservatives, antioxidants, sweeteners, novel counterions, etc)
  • EU Environmental risk assessment: initial evaluation to determine market penetration factor and predicted environmental concentration; guidance on any follow-on programme, liaison with CROs, study monitoring; preparation of environmental risk assessments for MAAs, ERAs for generic products and products containing existing drug substances
  • PDE (Permitted Daily Exposure; sometimes called ADE – Acceptable Daily Exposure) determinations in relation to setting health-based limits for carryover/cleaning limits in relation to drug-substance manufacturing and worker exposure
  • E-cigarettes: toxicological assessment of combustion products, vaping agents and flavourings