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Regulatory Affairs

Astrum offers comprehensive regulatory services ranging from consultancy to specific clinical trial submission support. We provide both European-wide knowledge and local insights that help you navigate the ever-changing regulatory landscape and ensure you can efficiently deliver your clinical studies.

Astrum’s teams have experience with the Clinical Trial Information System (CTIS), using different EU Authorities as Reference Member States and will guide you through the clinical trial submission process. We offer support at every step, including Investigational Medicinal Product Dossier (IMPD) preparation and Clinical Study Report (CSR) publishing.

Astrum can assist in preparing Module 2.4. (Non-clinical Overview), Module 2.5. (Clinical Overview), Module 2.7.1., and eCTD Module 5 ready-for-submission.

How can we help you?

Contact our expert team to discover how Astrum can bring value to your clinical development projects.


Other services

  • Clinical Development & Scientific Advice

    Ranging from first in human to post-marketing, Astrum’s clinical development expertise spans the entire development cycle, 
offering support every step of the way

  • Safety & Vigilance

    We provide complete pharmacovigilance and medical device vigilance services from the early stage of development, through to the medicinal products and medical devices marketing.

  • Medical Monitoring

    Acting as a point of reference for study team members and investigative 
sites, our Medical Monitors ensure the safety and integrity of the subjects 
throughout the trial