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Consultant offers services as a regulatory writer, regulatory affairs professional, regulatory publisher, and statistical analyst. Consultant has wide experience in writing the full range of preclinical and clinical regulatory documents, in submitting eCTDs for the US, Canadian, and EU authorities, in conducting data analyses, and in electronically integrating data and documentation to the eCTD.
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ph +1.318.929.4449www.epharmatechllc.com
EPharmaTech, LLC “ Science made clear
... with digital accuracy and speed. “
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)
ph +1.318.929.4449www.epharmatechllc.com
EPharmaTech, LLC
“ Science made clear... with digital accuracy and speed. “
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