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An Dao

I am currently a regulatory affairs/quality assurance professional but I am a scientist by training. I enjoy working... | Greater Houston, Greater Houston, United States

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An Dao’s Location Greater Houston, Greater Houston, United States

An Dao’s Expertise I am currently a regulatory affairs/quality assurance professional but I am a scientist by training. I enjoy working at the interface between business entities and governmental regulations, especially US FDA. Some highlights of my qualifications: • IND expert review for cell and gene therapy. IND writing and authorization for a Phase 1 study (NCT03691909) • Regulatory writing: early phase interactions (pre-pre-IND, pre-IND, RFD), eCTD format (IND, NDA, BLA,...) • Medical writing: clinical protocol, CSR • cGMP/cGTP and quality assurance: release criteria specifications, environmental monitoring, internal audits, root cause analysis and corrective and preventative actions, batch records, SOPs/change control, equipment qualification/validation, aseptic processing validation • IRB application • Project management • Preclinical/clinical protocol and process development • Regulatory consulting, especially early start ups • Extensive research experience in neurological animal models, testings, treatments, and survival surgeries • Grant and manuscript writing

An Dao’s Current Industry D And C Regulatory Consulting

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Work Experience

D And C Regulatory Consulting

Principal Regulatory Consultant

Wed Aug 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Present

Hope Biosciences

RA/QA Manager

Sat Jul 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Aug 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time)

Icell Kealex Therapeutics

Head of Regulatory Affairs

Sat Oct 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Jun 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time)

International Regulatory Affairs Services

Regulatory Affairs Consultant

Fri Jul 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Dec 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time)

Baylor College Of Medicine

Research Associate/Postdoctoral Fellow

Sun Sep 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Feb 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time)

University Of Houston College Of Pharmacy

Teaching Assistant

Sat Aug 01 2009 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Aug 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time)

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An Dao Email Addresses

[email protected] Email

An Dao Phone Number

No phone number available. Phone number

FAQ About An Dao

An Dao is located at
Greater Houston, Greater Houston, United States

An Dao is a
I am currently a regulatory affairs/quality assurance professional but I am a scientist by training. I enjoy working at the interface between business entities and governmental regulations, especially US FDA. Some highlights of my qualifications: • IND expert review for cell and gene therapy. IND writing and authorization for a Phase 1 study (NCT03691909) • Regulatory writing: early phase interactions (pre-pre-IND, pre-IND, RFD), eCTD format (IND, NDA, BLA,...) • Medical writing: clinical protocol, CSR • cGMP/cGTP and quality assurance: release criteria specifications, environmental monitoring, internal audits, root cause analysis and corrective and preventative actions, batch records, SOPs/change control, equipment qualification/validation, aseptic processing validation • IRB application • Project management • Preclinical/clinical protocol and process development • Regulatory consulting, especially early start ups • Extensive research experience in neurological animal models, testings, treatments, and survival surgeries • Grant and manuscript writing D And C Regulatory Consulting

An Dao currently works in the
D And C Regulatory Consulting

An Dao specializes in
I am currently a regulatory affairs/quality assurance professional but I am a scientist by training. I enjoy working at the interface between business entities and governmental regulations, especially US FDA. Some highlights of my qualifications: • IND expert review for cell and gene therapy. IND writing and authorization for a Phase 1 study (NCT03691909) • Regulatory writing: early phase interactions (pre-pre-IND, pre-IND, RFD), eCTD format (IND, NDA, BLA,...) • Medical writing: clinical protocol, CSR • cGMP/cGTP and quality assurance: release criteria specifications, environmental monitoring, internal audits, root cause analysis and corrective and preventative actions, batch records, SOPs/change control, equipment qualification/validation, aseptic processing validation • IRB application • Project management • Preclinical/clinical protocol and process development • Regulatory consulting, especially early start ups • Extensive research experience in neurological animal models, testings, treatments, and survival surgeries • Grant and manuscript writing

An Dao speaks the following languages:
No languages available.

An Dao has prior experience in the following industries:
Hope Biosciences , Icell Kealex Therapeutics , International Regulatory Affairs Services , Baylor College Of Medicine , University Of Houston College Of Pharmacy

An Dao has the following professional experience:
D And C Regulatory Consulting , Hope Biosciences , Icell Kealex Therapeutics , International Regulatory Affairs Services , Baylor College Of Medicine , University Of Houston College Of Pharmacy .