Regulatory Science Projects

We share our knowledge so we can better serve our clients

Our regulatory science projects enable us to stay up-to-date

Just published: Getting ready for the EMA Policy 0070 – Clinical Data Publication – Relaunch

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  • Navigating types of clinical study reports for optimal reporting of trial results Read more
  • Clinical development times for anti-cancer drugs shortened via accelerated regulatory pathways Read more
  • Clinical Trials Information System for clinical trial applications in Europe Read more
  • Promotional and informational Materials for Prescription Medication within the EU Read more
  • Upcoming changes to the CEP procedure and documentation Read more
  • Oligonucleotide therapy: Regulatory & Development challenges Read more
  • Analysis of approval times of anticancer drugs between 2010-2017 Read more
  • Geriatric Regulation: can we do without? Read more
  • Old medicines, new indications Read more
  • Orphan drug designation in the EU and the US – a critical review Read more
  • A detailed analysis of expedited regulatory review time of MA applications for new anti-cancer drug in the US and EU Read more
  • Post-Authorisation Studies Read more
  • Preclinical requirements for anticancer Drugs in the EU Read more
  • A Decade of Marketing Authorization Applications of Anticancer Drugs in the European Union Read more
  • ATMP challenges in the EU – lessons for future applications Read more
  • Drug Registration in Emerging Countries Read more
  • Implementation of Quality by Design Principles in Regulatory Dossiers of Medicinal Products in the European Union (EU) Between 2014 and 2019 Read more
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ProductLife Group’s mission is to improve human health by delivering regulatory & compliance services for the safe and effective use of medical solutions. PLG supports clients through the entire product life cycle, combining local expertise with global reach spanning more than 150 countries.

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