eCTDconsultancy
7 SlideShares 15 Followers
Personal Information
Organization / Workplace
Waalwijk, Noord-Brabant Netherlands
Industry
Medical / Health Care / Pharmaceuticals
Website
www.ectdconsultancy.com
About
eCTDconsultancy advises pharmaceutical and biotech companies on reducing time-to-submission by implementing strategies, processes and procedures related to scientific/ strategic and operational aspects of drug development. We apply a scientific approach to working with Regulatory Submissions that ensures the highest possible quality of Regulatory Dossiers, with an ultimate aim of providing benefits to applicant, agency and patient.
Tags
ectd esubmission ectdconsultancy ema regulatory operations dmf in ectd ro ec12342008 grouping regulatory affairs worksharing electronic submission adverse drug reactions xevmpd eudravigilance common technical document mah qdossier compliant submissions emea registration ra new variation regulation variations easmf common european submission portal cessp brexit ectd baseline gdpr electronic drug master file active substance master file asmf drug master file dmf entitity extraction text mining linked data idmp identification of medicinal products structured authoring electronic submissions baseline reformat xevprm psur pharmacovigilance var type
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Presentations

(7)
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The Science of Submissions Part IB - How to handle grouping and worksharing in eCTD

14 years ago • 2332 Views

The Science of Submissions Part IA - The principles of the new variation regulation

14 years ago • 1326 Views

Pharmacovigilance evmpd submission

13 years ago • 3832 Views

Pros and cons of eCTD baseline submissions

13 years ago • 3890 Views

IDMP and RIM: friend or foe?

10 years ago • 4332 Views

IDMP value beyond compliance

9 years ago • 743 Views

Submitting electronic Drug Master Files (DMF) and Active Substance Master Files (ASMF)

7 years ago • 3967 Views
Personal Information
Organization / Workplace
Waalwijk, Noord-Brabant Netherlands
Industry
Medical / Health Care / Pharmaceuticals
Website
www.ectdconsultancy.com
About
eCTDconsultancy advises pharmaceutical and biotech companies on reducing time-to-submission by implementing strategies, processes and procedures related to scientific/ strategic and operational aspects of drug development. We apply a scientific approach to working with Regulatory Submissions that ensures the highest possible quality of Regulatory Dossiers, with an ultimate aim of providing benefits to applicant, agency and patient.
Tags
ectd esubmission ectdconsultancy ema regulatory operations dmf in ectd ro ec12342008 grouping regulatory affairs worksharing electronic submission adverse drug reactions xevmpd eudravigilance common technical document mah qdossier compliant submissions emea registration ra new variation regulation variations easmf common european submission portal cessp brexit ectd baseline gdpr electronic drug master file active substance master file asmf drug master file dmf entitity extraction text mining linked data idmp identification of medicinal products structured authoring electronic submissions baseline reformat xevprm psur pharmacovigilance var type
See more