Link Consulting is your first choice for both full collaboration and strategic development
We explore the opportunity and create values for companies to partner and develop
Partnering
Partnering
Global in-licensing and
out-licensing projects
Investment and financing
Due diligence and negotiation support
Product and technology scouting
Development of partnering strategies (service, technology transfer, licensing, co-development)
Registration
Drug registration in China - CTA, MRCT, NDA, BLA and other supplement or variation
Drug registration in US – IND, NDA, BLA, ANDA and other variation
Submission strategy consultation, plan and risk assessment
Quality control and management for dossier
CDE and US FDA consultation and panel meetings including Pre-IND / End of Phase I or II meeting / Pre-NDA meeting
Thorough knowledge of ICH regulations in China and US, as well as that of Asia Pacific countries
Clinical Service
Program / Protocol design
Scientific Leadership
Project Management
Clinical Monitoring
Medical Monitoring
Safety Services including Endpoint Adjudication and DSMBs
Data Management
Statistics
Health Economics
Consulting
Market research
KOLs/Physician interviews
Business strategy
Portfolio evaluation and optimization
Tech transfer support
Gap analysis
Competitive product analysis
Reimbursement strategy consulting
Patent analysis