Regulatory Affairs - Integrated Services - UnionClin Pharmaceutical

Strategy Consultation
Regulatory Affairs
Medical Affairs

Medical Writing Medical Monitoring
Clinical Operations

Project Management Clinical Center Management and Monitoring Clinical Center Start-up Project Risk Management Data Management and Quality Control Investigational Drug Management Trial Documentation Management Meeting Organization and Coordination
Data Management & Statistics

Biostatistics Data Science Statistical Analysis and Programming Biometrics Platform Biometrics Innovation Service
TrialMaster (EDC and e-Solutions)
Clinical Pharmacology

Clinical Pharmacology Modeling and Simulation Strategy Planning
Pharmacovigilance
IRC Service

IRC Service Common Efficacy Evaluation Criteria Service Process
Bioanalysis Lab

Chemical Drugs Biologics
Site Management (SMO)

Center Services Specific Services
FSP Service
Recruitment Management

Basic Service Contents Upgraded Service Content

Regulatory Affairs

We provide project management and practical operations of registration affairs for the full lifecycle of drugs. We maintain stable relations and seamless communication with regulatory authorities, and have profound experience in the submission of application materials to CDE for approval.

Service Content

Registration strategy development: IND/NDA preparation for FDA/CDE, application plans/key milestones

Product positioning analysis: Product feature analysis, status of similar products, product development plan

Registration material writing/review: Application material review/analysis, preparation of writing documents in eCTD format

Registration communication/submission: Initiation of Pre-IND, communication documents with CDE, formal IND submission/maintenance

Supporting Simultaneous Submissions in China and US and Global Regulatory Affairs Services
Developing Registration and Marketing Strategies by Domestic Clinical Experts
Smooth Communication with CDE Clinical Review Experts