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:

+420 224 910 672

(from 09.00-17.30 CET)

+420 226 251 459

(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:

+420 224 910 672

(09.00-17.30 CET)

+420 226 251 459

(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.

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:


Drafting addendum to clinical overview


Preparation of Development Safety Update Reports


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


Preparation and submission of periodic safety update reports