Home Dossier Development Services You are here Contact us Regulatory Dossier Writing We understand that a consistent and compliant regulatory dossier is the key to obtaining timely clinical trial approval and smooth marketing authorisation (MA). However, the path to approval may be burdensome. That’s where our dossier development team comes in, helping you to accelerate the drug approval process. For more than 20 years we have focused on Chemistry, Manufacturing & Control (CMC) subjects, hence we can offer you in-depth knowledge, insight and unparalleled experience. Our regulatory dossier writing and formatting services include: Focus on module 3 and 2.3-2.7 quality sections for IMPD, IND and full MA or NDA Expertise to adapt level of detail according to all development phases (phase 1-4) Ability to cover all territories (US FDA, EMA, Canada, Japan Brazil, Row) Electronic common technical document (eCTD) compilation and reformatting Readability testing and writing of patient leaflets Translations Back to dossier development Services Scientific Report Writing Quality Document Writing Regulatory Dossier Writing Submission and Liaison Highlights Capabilities Contact us today Get in touch with us to discuss your next project Register for our newsletter Do you wish to remain up to date with drug development insights, industry trends & Ardena news? Click here to register Services Drug Substance Solid State Research Drug Product Clinical Logistics Bioanalysis Dossier Development Nanomedicine Navigation About Us Careers News & Insights Contact Legal entities General Terms and Conditions Contact details Ardena Kleimoer 4 B-9030 Mariakerke Belgium Telephone +32 9 267 65 00 Fax: +32 9 267 65 10 © Ardena Holding NV 2021 LinkedIn Sitemap Privacy Policy Ardena respects your right to privacy Your ability to make informed choices about the use of your information is important to us. This cookie statement details which cookies we or other parties can place on your device and how we and other parties use this information within Ardena. If you have any comments or questions about this cookie statement or the collection and use of your personal data, please contact our data protection GDPR@ardena.com More info. Set preferences Accept cookies