Core Services

Full-cycle support across R&D, clinical development and registration

We provide strategic, documentation, communication and execution support across China, the US and Europe, helping programs align with regulatory expectations from the beginning.

01 / Regulatory

Global Drug Registration

NMPA, FDA and EMA regulatory strategy; IND, NDA, BLA and CTA filings; eCTD compilation and agency communication.

Regulatory strategyFiling documentsAgency communicationeCTD

Design synchronized or phased filing pathways across China, the US and Europe
Prepare key pre-IND, IND, NDA and BLA materials
Support CDE, FDA and EMA meeting preparation and responses

02 / Clinical

Clinical Development Strategy

Clinical development planning around TPP, indication selection, endpoints, sample size, bridging studies and international multi-center trials.

TPPPhase I-IV designBridging strategyMRCT

Develop clinical plans aligned with registration objectives
Optimize endpoints, eligibility criteria and statistical assumptions
Assess the acceptability of overseas data for China filings

03 / Strategy

R&D Strategy and GAP Analysis

Identify gaps between current project status and regulatory requirements, then map the optimal path for supplementary studies and filing readiness.

GAP analysisRisk identificationPCC selectionPrioritization

Evaluate CMC, non-clinical, clinical and regulatory evidence chains
Recommend key supplementary studies and communication milestones
Support early candidate screening and TPP metric design

04 / Business

Investment and BD Empowerment

Technical due diligence, valuation support, competitive landscape review and license-in/license-out support for investors and industry partners.

Technical DDCompetitive analysisBD supportProject evaluation

Assess project quality from scientific, clinical, regulatory and commercial angles
Identify core risks, development cost and key milestones
Support business negotiation and licensing materials