Reporting of adverse events ONLY

Patients should always seek the advice of a doctor or pharmacist in case of adverse events.

If you wish to report an adverse event to ELC Group s.r.o., please find the contact information below:

00420 224 910 672

(from 09.00-17.30 CET)

00420 723 694 460

(non-stop 24/7)

To contact us about any other issue please call:

+420 22 491 0000or our regional offices.

Hlášení nežádoucích príhod

Pacienti by meli vždy požádat o radu svého lékare nebo lékárníka v prípade výskytu nežádoucích príhod.

Pokud chcete nahlásit nežádoucí príhodu spolecnosti ELC Group s r.o., prosím využijte kontaktních údaju níže:

00420 224 910 672

(09.00-17.30 CET)

00420 723 694 460

(non-stop 24/7)

Pro záležitosti, které se netýkaji farmakovigilance, kontaktujte prosím recepci:

+420 22 491 0000 nebo naše další pobočky.

Medical Writing

ELC provides a comprehensive medical writing service for regulatory submissions, scientific communications and medico-marketing materials for diverse therapeutic areas, and for all phases of the product life cycle. We ensure that you gain accurate, consistent and regulatory-compliant documents in a cost-effective, timely and flexible manner.

400+
expert writing projects

Our services include:

  • Drafting biowaiver justifications
  • Clinical trial protocol and report writing
  • Drafting Investigator’s Brochures and informed consent documents
  • Literature search reports
  • Common Technical Document (CTD) module writing, including:
    • Module 2.4 preparation/update (Pre-clinical overview)
    • Module 2.5 preparation/update (Clinical overview)
    • Module 2.6 preparation/update (Pre-clinical summaries)
    • Module 2.7 preparation/update (Clinical summary)
    • Module 4 compilation
    • Module 5 compilation
  • Writing waiver reports for Environmental Risk Assessments
  • Permitted daily exposure (PDE) report writing
  • Summary of product characteristics (SPC), Product information (PI) and Product/Patient
  • Information Leaflet (PIL) writing
  • Writing publications, journal articles/manuscripts (research articles), abstracts, posters and presentations for scientific meetings and conferences
  • Writing medical marketing documents- product monographs, brochures and sales force training manuals

In relation to pharmacovigilance we offer medical writing services including:

ACO

Drafting addendum to clinical overview

DSUR

Preparation of Development Safety Update Reports

RMP & REMS

Preparation and updates of Risk Management Plans and Risk Evaluation and Mitigation Strategies

PSUR/PBRER & PADER

Preparation and submission of periodic safety update reports