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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 financin​g

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

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