With in-depth understanding of scientific writing, CMC documentation requirements, and regulatory processes, Ardena fast-tracks your product towards authority approval on a global basis.
We ensure the preparation and negotiation of your applications, from the initial scoping, through drafting of source documentation, towards compilation of quality dossiers, and post approval.
Acting as the accountable expert within your team, we keep track of compliance and add regulatory insights into the decision-making process. Striving for a seamless flow of information in quality documentation such as Module 3, we reduce the risks and timelines of our clients.
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Our team members share deep, scientific understanding and insights into their respective fields of expertise.