Highlights

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 stem cells.

Our regulatory experts also have extensive experience of regulations covering drug substances, both small and large molecule, pharmaceutical excipients, herbal and vitamin and mineral products, packaging materials and medical devices.

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 can be a resource intensive challenge for pharmaceutical companies and is a key area where we can help.

Ardena’s dossier development team supports you by assessing and interpreting (new) legislation on your behalf. Based on case by case assessments of the actual procedures or principles already in place at our customers’ facilities, we’ll assist you with the implementation of the new legislation to ensure that you achieve compliance.

As we continue to monitor the updates of the rulings, we’ll ensure you remain compliant with the (EU/ICH) guidance and legislation for the long term.

Below are some examples of our activities in this area:

  • Implementation of a formalised GMP risk assessment of excipients and supplier qualification
  • Implementation of Q3D elemental impurities
  • Updating medical device dossiers in line with the new Medical Device Regulation (MDR)
  • Compliance with XEVMPD and ISO IDMP
  • Monitoring updates in EP/USP relating to a specific product
  • EU submissions of Marketing Authorisation (MA) applications as per the Common European Submission Portal (and other future SPOR requirements)