We specialise in marketing authorisation approval of pharmaceuticals and a variety of health care products including cosmetics and medical devices. Tailored to market access of your products starting from regulatory planning.
• Delivering bespoke regulatory and market access solutions tailored to your products
• Consultants with many years’ experience in regulatory affairs and market access
• Open communication throughout the process and timely feedback
• Focused on achieving the results you need to grow or launch your business
• Compiling documentation in eCTD format and adaptation to local requirements
• Local adaptation of your global pharmacoeconomics model for local HTA requirements
Discuss your project and requirements - We will arrange a call and ask you about your product that you would like to launch and what your business objectives are.
Your confidentiality matters! - Once we have an overview of what you'd like to achieve, we will sign a confidentiality agreement to kick off the project.
Cost estimate - We can provide you with a regulatory budget that includes official and non-official costs.
Let's start! - We will produce a project overview document which will list all agreed deliverables and costs. Once this is decided through a service agreement, the project will then be scheduled in.
Reporting back - For any stage of the whole process, we will be in touch for further questions through e-mails, teleconferences or video-conferences and there will be regular reporting of any milestone.
Alive collaboration - We will talk in detail about what elements are required where, and how the process will be handled starting from the beginning of the project until the end of the process.
Process - We will have a project consultant in touch with you throughout the whole process. Daily and weekly reports will be delivered to your mailbox.
Documentation - We will create the local documentation based on your core documentation and send you templates to start and work with for the local requirements. Any translations required are handled by our side with an additional cross charging.
Submission - We will continue to build all required documentation while sending you the cover letters for sign off.
To be continued - We will keep in touch to review how the process is performing, and continue to grow the collaboration together.