Set your dossier up for success with expert strategic guidance, and leverage over 72 combined years of experience in Regulatory Affairs. Explore the comprehensive services we provide, including…
Full dossier gap analysis
We can evaluate your dossier against industry standards and regulatory requirements and pinpoint exactly what’s missing for successful submission, advising and supporting you with all the steps needed to correct it. Your corrected dossier will be fully compliant with the requirements of the specific market where the application is made, making validation faster, and with far fewer, or no letters of deficiency issued during the evaluation process, resulting in a much faster time to market.
Full dossier preparation - Modules M1-M5
We can create each section of your dossier from scratch with the raw manufacturing documentation provided. Our experts challenge and collaborate with manufacturers to ensure that all the presented dossier information is both correct and supports each section efficiently.
CMC - Chemistry, Manufacturing and Control
We can write the CMC part of the dossier for your medicinal product based on the information that defines the raw materials chemical characteristics, the manufacturing process, the quality control testing, the finished products specifications and its stability together with additional information.
GxP inspection support
From Good Manufacturing Practice (GMP) inspections to Good Distribution Process (GDP) inspections, we’ll provide the guidance you need for inspection approval.
WDA application support
Rely on Arriello to shorten your WDA application timeline so you quickly reach your target market.
Post submission approval, we can help you efficiently monitor and manage your products throughout their life cycle by ensuring any applicable changes are always submitted on time.
In short, we can create a faster, better, smarter life cycle strategy for any post approval situation, adapting to changes driven by manufacturing, commercial or legislation to keep you fully compliant at all times.
Arriello’s continued support includes…
Stay one step ahead. We can help you define and implement your strategy for the preparation and submission of any type of variation.
Market Authorization Transfer (MAT) support
When it’s time to transfer your MA, we’ll walk you through the process...step by step.
Reference Member State (RMS) Transfer
As part of your product life-cycle market strategy you may need to switch to another RMS. No problem, we can guide you and provide a full support service to make switching easy.