Navigating the complex regulatory requirements for inhaled products is critical to the success of your development programme.
Our in-house regulatory expert team can provide a broad range of regulatory services for inhalation devices, combination products and drug products.
Specifically:
Global Regulatory development strategy and submission expertise (NCE’s and generics)
Proven global regulatory success with medical devices and combination products including compliance with the EU Medical Device Regulation (MDR)
Support compilation of Device Technical Files and liaising with Notified Bodies
Extensive experience in regulatory agency interactions and authoring of regulatory submission documents, including responding to regulatory requests for information during the review process
Global pharmacovigilance and device vigilance capabilities including appropriate reporting to Competent Authorities in both the development and post-marketing phase