Dossier Development

Dossier and drug product developed together. The smartest path to your clinical milestones.

For an overview, consider our brand new info sheet here.

Pharmaceutical dossier preparation services form an important part of our role in navigating customers through drug development.

Dossier preparation is a key part of any drug development program. Gathering the product information, clinical and manufacturing data regulatory agencies use to assess a drug is a complex process that involves multiple stakeholders.

Comprehensive pharmaceutical dossier preparation services

For some companies, dossier production can be a resource intensive, costly process that can delay or even derail the drug development process.

To that end, Ardena offers a comprehensive range of pharmaceutical dossier preparation services that streamline production of the registration file.

Our dossier-centric approach to projects means our customers stay ahead of the game when it comes to advancing products to clinic. From early formulation development through manufacturing and bioanalysis, we keep your dossier in mind during every stage of the process to ensure the data required is always available.

Our expert dossier development team will work with you to compile your regulatory dossier in parallel with drug development. This approach accelerates the process and affords us greater adaptability and flexibility.

Ardena employees working in dossier development