Services
End-to-End Expertise. Every Stage.
From first-in-human to commercial launch and beyond — our services span the full development lifecycle, tailored to your specific needs and stage.
Drug Development Strategy
- Target product profile (TPP) development
- Preclinical & translational strategy
- Clinical development planning (Phase I–IV)
- Biomarker & companion diagnostic strategy
- Formulation & CMC advisory
- Clinical trial design & optimization
Device Development & Engineering
- Design controls & development planning
- Human factors engineering strategy
- Verification & validation planning
- Predicate device analysis
- Risk management (ISO 14971)
- Design transfer & manufacturing readiness
Regulatory Strategy
- FDA pathway assessment (510(k), PMA, De Novo, BLA, NDA)
- Pre-submission & breakthrough designation strategy
- EU MDR / IVDR compliance planning
- Global regulatory strategy harmonization
- Advisory committee preparation
- Post-market regulatory planning
Commercialization
- Market access & reimbursement strategy
- Pricing & health economics (HEOR)
- Launch planning & execution
- KOL engagement strategy
- Competitive intelligence & landscape analysis
- Brand positioning & commercial due diligence
Business Development
- Licensing & partnership strategy
- Asset valuation & transaction support
- Due diligence (scientific & commercial)
- Portfolio strategy & prioritization
- Investor materials & fundraising support
- Strategic alliance structuring
Program Management
- Integrated development planning
- Cross-functional team leadership
- Budget forecasting & resource planning
- Milestone tracking & governance
- Vendor selection & management
- Risk assessment & mitigation planning
Across the Development Lifecycle
We engage at any stage — and our value compounds the earlier we're involved.
01
Discovery
Target ID & Validation
02
Preclinical
IND-Enabling Studies
03
Clinical
Phase I–III Trials
04
Regulatory
Submissions & Approval
05
Commercial
Launch & Market Access