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Regulatory Affairs

Clinical Operations

Medical Services

Regulatory Affairs

Data Management

Pharmacovigilance

Real World Evidence

Cardiac Safety Assessment

Full Drug Lifecycle Regulatory Submission Management Services

Pre-clinical

Phase I-III

Post Market

Pre-IND
Study startup submission

Clinical learning phase

Pre-NDA communication
Execute product positioning

IND

NDA

eCTD publishing
Regulatory consulting on development strategy and operational execution
Compliance consultation on clinical research, manufacturing, and distribution

A team with implementation experience to carry out projects in an transparent and compliant manner.

Provide customized services guided by client needs and regulatory requirements.

Extensive Project Experience To Help Accelerate The Process Of Product Development And Marketing

Registration project experience

01CDE communications and consulting

02Human genetic resources applications

Therapeutic areas

Oncology, cardiovascular, infection, digestion, endocrine, immunology, ophthalmology and otorhinolaryngology, psychoneurology, pediatrics, hematology

01
Human genetic resources application experience

01International cooperative scientific research approval

02Collection approval

03Change approval

04Summary report

05Data provided for filing

02
eCTD project experience

01 Submission type: US IND/NDA/ANDA/BLA submissions
EU MAA submissions

02 Service content: Word file formatted editing and file completion
PDF file editing
eCTD generation and validation

03 Quantity of submitted projects: 30+ NDA;50+ IND;15+ BLA;
25+ ANDA Submissions to FDA;
5+ MAA Submission to EMA;

03

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