Integrating science, regulation, and strategy into one development vision.
We provide an integrated approach that combines regulatory strategy and submission, clinical project integration and management, and independent auditing, helping biopharma companies conduct efficient, compliant, and value-driven cross-border trials without delaying existing trial progress.Regulatory Strategy & Submission
We design and implement cross-border regulatory pathways to align development with business objectives and accelerate approvals.
- Strategic consulting: IND planning, U.S.–China dual filing, and development roadmaps.
- Regulatory execution: IND preparation, bridging studies, and submission.
- Agency interaction: Facilitate communications with FDA, CDE, and other agencies to secure regulatory alignment.
Clinical Integration & Project Management
We represent the sponsor’s interests in coordinating and supervising all aspects of trial operations.
- Vendor selection & bidding: Identify, evaluate, and manage CROs, SMOs, and specialized partners through transparent screening and bidding processes.
- Process support: Provide hands-on oversight to ensure service providers deliver on quality, budget, and timelines.
- Cross-border harmonization: Align standards and data between FDA and CDE for global acceptance.
- Patient & PI engagement: Design and manage recruitment strategies and PI networks to accelerate enrollment.
Project Audit & Oversight
We provide independent auditing of trial operations to ensure efficiency, compliance, and client protection.
- Progress review: Regular assessment of project milestones and deliverables.
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Vendor performance: Evaluate CRO/SMO execution quality and risk areas.
- Cost & compliance check: Ensure budgets & contracts stay within expectations; ensure data integrity meets global regulatory standards.
- Client-side advocacy: Act as a safeguard for sponsor interests throughout the project lifecycle.
BD Enabling Support
Through our Integrated Product Development (IPD) Engine, we incubate and shape assets into BD-ready opportunities by embedding clinical strategy, regulatory pathways, and differentiation from the outset.
- Clinical strategy integration: Design trial pathways with clinical, regulatory, and commercial endpoints in mind.
- Differentiation & validation: Incorporate KOL insights and competitive analysis to strengthen positioning for target market.
- Regulatory alignment: Build development plans that meet global submission and approval requirements.
- Deal readiness: Package assets with the data, structure, and strategy needed to attract partners and investors.
CMC Consulting
Our CMC advisory team builds scalable, compliant manufacturing roadmaps for biologics and small-molecule products. We evaluate process robustness, comparability data, and analytical readiness to meet FDA and ICH standards. Through strategic vendor oversight and risk mapping, we enable biotech companies to advance development efficiently while preserving quality and regulatory continuity.