Medical writing

illev Pharma East has a highly educated and dedicated team of international experts with many years of experience in Pharmaceutical industry.
illev Pharma East has a highly educated and dedicated team of international experts with many years of experience in Pharmaceutical industry.

Medical writing

OUR SERVICES

Medical writing of regulatory documentation:

  • Clinical Overview and Summary (all legal basis applications)
  • Non-clinical Overview and Summary (all legal basis applications)
  • Clinical Study Reports (CSRs), protocols, Investigators brochures (IBs), safety narratives
  • Environmental Risk Assessment
  • SmPC, PIL
  • Bridging reports (readability)
  • Writing of medical / pharmaceutical publications for journals

Medical writing in Pharmacovigilance:

  • Company Core Data Sheet, Company Core Safety Information
  • Periodic Safety Update Reports (PSUR / PBRER)
  • Risk-benefit reports
  • Signal detection
  • Risk Management Plan (RMP)
  • Medical assessment of adverse drug reactions
  • Medical Enquiries

 

illev Pharma East has a highly educated and dedicated team of international experts with many years of experience in Pharmaceutical industry.
medicine

I think it is quite remarkable how we as humans have improved in the pharmaceutical and medical fields in the last 100 years. I am sure that we will remain courageous and continue to innovate!

Martina

Božíková

MASTER'S in PHARMACY REGULATORY AFFAIRS & PHARMACOVIGILANCE OFFICER