Regulatory Service

 

Category: *CRO

Exhibitor: EFFICIENT PHARMA MANAGEMENT CORP.

Booth No: N/A

 

Characteristic

 

EffPha provides high quality, comprehensive regulatory services to our clients and can satisfy their needs for meeting the regulatory requirements of different countries. Our regulatory services broadly cover all regulatory related activities from IND to NDA/BLA, including pre-IND meeting, IND submission, EOP1 and EOP2 meeting, pre-NDA meeting and NDA submission. With the extensive experience of our regulatory team, we have established good knowledge, understanding and relationship with the health authorities and have achieved 100% IND submission approval rate so far. EffPha serves as the regulatory representatives in Taiwan and the US, and through our global partners, we can also assist in the submission in other countries worldwide.

We deliver the following services:
● Regulatory Gap Analysis
● Taiwan FDA/CDE Consulting Meeting Arrangement and Package Preparation 
● US FDA Pre-IND Meeting Arrangement and Package Preparation 
● Technical Writing/ Compilation (ICH/CTD)
● eCTD Publishing and Filing to US FDA
● IND Submission/ Maintenance
● Bridging Study Evaluation Application
● Designation for Expedited Review
● PMF Application
● NDA Submission (NDA, BLA, ANDA)
● Post-Approval Changes Application

 

Other Products

 

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  Clinical Operation

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  Statistical Analysis

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  Non-Clinical Study Management

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  Scientific Evaluation & Support

 

 

 

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