Dossier Development

Dossier Development

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Dossier and drug product developed together. The smartest path to your clinical milestones. 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. - Scientific Report Writing - Quality Document Writing - Regulatory Dossier Writing - Submission and Liaison
ArdenaArdena is a pharmaceutical CDMO that guides companies through the hurdles and challenges of drug development to help create effective and compliant drug substance and drug products for clinical trials. Ardena provides you with an integrated service offering including solid state chemistry, API & nanomedicines development and manufacturing, analytical & formulation development, drug product manufacturing, bioanalytical, drug discovery and dossier development services. Headquartered in Ghent, we have facilities in the Netherlands, Belgium, Sweden and Latvia, serving a global customer base, ranging from emerging biotech to tier-one pharmaceutical companies.

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