Our Strategic Consulting services can be found below:

• Regulatory strategy roadmaps and program assessments
• Regulatory fundamentals (educating stakeholders)
• Gap Analysis
• Global major filings including simultaneous submissions
• Clinical trial plans and applications (IND, CTA)
• Nonclinical foundations (animal and PK modeling)
• Health Authority interactions (scientific/parallel advice, FDA milestone meetings)
• Advisory boards
• Designations and expedited pathways
• Global pediatric development plans
• Chemistry, Manufacturing and Controls (CMC)
• Medical and scientific (regulatory) authoring
• Risk management plans and labeling
• Small molecules, biologics, cell, and gene therapy
• Global market analysis and regulatory intelligence
• R&D plans
• Due diligence (asset evaluations, M&A)
• Portfolio analysis
• Label expansion (indication assessments)
• Discover and early-stage viability evaluations
• Target Product Profile (TPP)