Human medicines

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.

Human medicines

We have expertise in various human medicines types: innovative, generics, non-prescription (OTC), herbal, biosimilars, biological, orphan, paediatric, advanced therapy (ATMP).

OUR SERVICES

  • Cost effective regulatory strategies to gain competitive advantage for new product development

For existing registered products (re-development, re-registration, etc.):

  • Project management
  • Compliance check/due diligence, updating and reformatting of files
  • Choosing the most appropriate procedure type
  • Handling all types of registration procedures for various products in the eCTD.
  • Consultation on a legal basis and classification of products
  • Handling registration procedures in all EU Member States.
  • Preparation of Modules 1-5
  • Life cycle management
  • Regulatory requirements, strategies, and the knowledge of the global product dossier
  • CMC documentation preparation (API and FDF)
  • EDQM – obtaining CEP
  • Environmental risk assessment (ERA)
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