<ul><li>[email_address] </li></ul><ul><li>ph +1.318.929.4449 </li></ul><ul><li>www.epharmatechllc.com </li></ul><ul><li>E ...
<ul><li>[email_address] </li></ul><ul><li>ph +1.318.929.4449 </li></ul><ul><li>www.epharmatechllc.com </li></ul>Specializi...
<ul><li>1.0 Investigators brochures 1.0 Package inserts 1.0 Summary product of    characteristics 1.0 P atient leaflets 1....
Anti-inflammatory   Cardiology   Central nervous system  Dermatology  Endocrinology  G astroenterology  G ynecology  Immun...
<ul><li>IND  – Investigative New Drug CTA  – Clinical Trial Application NDA  – New Drug Application BLA  – Biologic Licens...
<ul><li>Tables </li></ul><ul><li>Listings </li></ul><ul><li>Graphs </li></ul><ul><li>CDISC conversions of legacy databases...
<ul><li>Drug development </li></ul><ul><li>  Pharmaceutical industry  standards </li></ul><ul><li>  Structured product  la...
<ul><li>Certifications: </li></ul><ul><li>American Medical Writers Association Professional Development Certification </li...
<ul><li>Professional Memberships and Affiliations: </li></ul><ul><li>American Medical Writers Association (AMWA) </li></ul...
<ul><li>[email_address] </li></ul><ul><li>ph +1.318.929.4449 </li></ul><ul><li>www.epharmatechllc.com </li></ul><ul><li>E ...
 
<ul><li>Thank you for viewing this presentation! </li></ul><ul><li>We look forward to discussing your writing, publishing,...
Upcoming SlideShare
Loading in …5
×

EPharmaTech,LLC Services / Susan Bairnsfather Contract Medical Writer / Contract Regulatory Writer / Regulatory Affairs Professional / Statistical Analyst

2,344 views

Published on

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.

Published in: Health & Medicine
0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total views
2,344
On SlideShare
0
From Embeds
0
Number of Embeds
51
Actions
Shares
0
Downloads
10
Comments
0
Likes
0
Embeds 0
No embeds

No notes for slide

EPharmaTech,LLC Services / Susan Bairnsfather Contract Medical Writer / Contract Regulatory Writer / Regulatory Affairs Professional / Statistical Analyst

  1. 1. <ul><li>[email_address] </li></ul><ul><li>ph +1.318.929.4449 </li></ul><ul><li>www.epharmatechllc.com </li></ul><ul><li>E P harmaTech, LLC </li></ul><ul><ul><ul><li> “ Science made clear </li></ul></ul></ul>... with digital accuracy and speed . “
  2. 2. <ul><li>[email_address] </li></ul><ul><li>ph +1.318.929.4449 </li></ul><ul><li>www.epharmatechllc.com </li></ul>Specializing in electronically integrated regulatory writing and statistical analyses for global esubmissions E P harmaTech, LLC
  3. 3. <ul><li>1.0 Investigators brochures 1.0 Package inserts 1.0 Summary product of  characteristics 1.0 P atient leaflets 1.0 Environmental assessments 2.0 Clinical overviews 2.0 Nonclinical overviews 3.0 Quality 4.0 Nonclinical study reports 5.0 Integrated summaries of efficacy 5.0 Integrated summaries of safety 5.0 Pharmacokinetic summaries 5.0 Clinical study reports 5.0 Protocols 5.0 Statistical analyses plans 5.0 Subject narratives  Regulatory content templates  510K (devices) </li></ul>Module 1 Module 3 Module 4 Module 5 2.1 2.2 2.3 2.4 2.5 2.6 2.7 Module 2 eCTD
  4. 4. Anti-inflammatory Cardiology Central nervous system Dermatology Endocrinology G astroenterology G ynecology Immunology Obesity Oncology Ophthalmology Pulmonology Rheumatology Urology Women's health
  5. 5. <ul><li>IND – Investigative New Drug CTA – Clinical Trial Application NDA – New Drug Application BLA – Biologic License Application MAA – Marketing Authorization Application NDS – New Drug Substance 510K – Device SPL – Structured Product Labeling </li></ul>
  6. 6. <ul><li>Tables </li></ul><ul><li>Listings </li></ul><ul><li>Graphs </li></ul><ul><li>CDISC conversions of legacy databases </li></ul><ul><li>Subject narrative created by exporting clinical data directly to MS Word template of any format </li></ul>
  7. 7. <ul><li>Drug development </li></ul><ul><li> Pharmaceutical industry standards </li></ul><ul><li> Structured product labelling </li></ul><ul><li> Biostatistics </li></ul><ul><li> Content template creation </li></ul><ul><li>  </li></ul>… on Site … with Webinars
  8. 8. <ul><li>Certifications: </li></ul><ul><li>American Medical Writers Association Professional Development Certification </li></ul><ul><li>American Medical Writers Association Advanced Writers Certification </li></ul><ul><li>American Medical Writers Association Pharmaceutical Writers Certification </li></ul><ul><li>  </li></ul>
  9. 9. <ul><li>Professional Memberships and Affiliations: </li></ul><ul><li>American Medical Writers Association (AMWA) </li></ul><ul><li>European Medical Writers Association (EMWA) </li></ul><ul><li>Regulatory Affairs Professionals Society (RAPS) </li></ul><ul><li>Drug Information Association (DIA) </li></ul><ul><li>Health Level 7 Technical Team for Structured Product Labeling (HL7) </li></ul><ul><li>Clinical Data Interchange Standards Consortium (CDISC) - CDASH project </li></ul><ul><li>Pharmaceutical SAS Users Group (PSUG) </li></ul>
  10. 10. <ul><li>[email_address] </li></ul><ul><li>ph +1.318.929.4449 </li></ul><ul><li>www.epharmatechllc.com </li></ul><ul><li>E P harmaTech, LLC </li></ul><ul><ul><ul><li> “ Science made clear </li></ul></ul></ul>... with digital accuracy and speed . “
  11. 12. <ul><li>Thank you for viewing this presentation! </li></ul><ul><li>We look forward to discussing your writing, publishing, and statistical projects! </li></ul>

×