epharmatech,llc services / susan bairnsfather contract medical writer / contract regulatory writer /...

sbairnsfather@epharmatechllc.com

ph +1.318.929.4449www.epharmatechllc.com

EPharmaTech, LLC “ Science made clear

... with digital accuracy and speed. “

sbairnsfather@epharmatechllc.com

ph +1.318.929.4449www.epharmatechllc.com

Specializing in electronically integrated regulatory writing

and statistical analyses for global esubmissions

EPharmaTech, LLC

1.0 Investigators brochures1.0 Package inserts1.0 Summary product of 

characteristics1.0 Patient leaflets1.0 Environmental assessments2.0 Clinical overviews2.0 Nonclinical overviews3.0 Quality4.0 Nonclinical study reports5.0 Integrated summaries of

efficacy5.0 Integrated summaries of

safety5.0 Pharmacokinetic

summaries5.0 Clinical study reports5.0 Protocols5.0 Statistical analyses plans5.0 Subject narratives Regulatory content templates 510K (devices)

Module 1

Module 3 Module 4 Module 5

2.1

2.2

2.32.4 2.5

2.6 2.7

Module 2

eCTD

Anti-inflammatory Cardiology Central nervous system Dermatology Endocrinology Gastroenterology Gynecology Immunology Obesity Oncology Ophthalmology Pulmonology Rheumatology Urology Women's health

IND – Investigative New Drug

CTA – Clinical Trial Application

NDA – New Drug Application

BLA – Biologic LicenseApplication

MAA – Marketing Authorization Application

NDS – New Drug Substance

510K – Device

SPL – Structured Product

Labeling

Tables

Listings

Graphs

CDISC conversions of legacy databases

Subject narrative created by exporting clinical data directly to MS Word template of any format

Drug development

Pharmaceutical industry standards

Structured product labelling

Biostatistics

Content template creation

… on Site

… with Webinars

Certifications:

American Medical Writers Association Professional Development Certification

American Medical Writers Association

Advanced Writers Certification

American Medical Writers Association Pharmaceutical Writers Certification

Professional Memberships and Affiliations:

American Medical Writers Association (AMWA)

European Medical Writers Association (EMWA)

Regulatory Affairs Professionals Society (RAPS)

Drug Information Association (DIA)

Health Level 7 Technical Team for Structured Product Labeling (HL7)

Clinical Data Interchange Standards Consortium (CDISC) - CDASH project

Pharmaceutical SAS Users Group (PSUG)

sbairnsfather@epharmatechllc.com

ph +1.318.929.4449www.epharmatechllc.com

EPharmaTech, LLC

“ Science made clear... with digital accuracy and speed. “

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