Our experienced regulatory submission and dossier development team has expertise in all areas of drug development.

Our staff knows how to prepare regulatory submissions for all types of medicines, from chemical drug products to biotechnology drug products such as vaccines, monoclonal antibodies, peptides and oligonucleotides.

Our regulatory experts also have extensive experience with regulations covering drug substances, both small and large molecule and drug products

We have comprehensive experience complying with regulations in all major regulated markets, including the US and Europe. Our team also monitors regulatory developments in emerging and fast-growing markets to ensure our customers maintain compliance.

Monitoring, interpretation & implementation of regulatory environment

The (European/ICH) pharmaceutical legislation environment is very dynamic and fast changing. Maintaining compliance with new legislation and guidance can be a resource intensive challenge for pharmaceutical companies and is a key area where we can help.

Ardena’s CMC regulatory team supports you by assessing and interpreting (new) legislation and guidance on your behalf to ensure that you  remain compliant

Below are some examples of our activities in this area:

  • CMC/Scientific report writing for drug substance and drug product
  • Module 3 writing (IMPD/IND and MAA/NDA)
  • CMC regulatory advice