Our Strategic Consulting Services
Our Strategic Consultancy is underpinned by unrivaled subject matter knowledge in every key area of Regulatory Affairs, Quality Assurance and Clinical Development.
Our Strategic Consulting Services
Our Services
Our Strategic Consulting services can be found below:
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- 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)
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