Our experienced medical group can critically appraise and support clinical development programmes and protocol development.
We offer medical insight into pharmacovigilance activities and can act as Medical Monitor for clinical studies through all phases of drug development.
In addition, we have extensive experience in regulatory agency interactions and can provide support for the authoring of the various regulatory submission documents.
Regulatory, Device Vigilance & Pharmacovigilance
Navigating the complex regulatory requirements for inhaled products is critical to the success of your development programme.
Our in-house regulatory team can support with:
Global regulatory development strategy and submission expertise (NCEs and generics)
Proven global regulatory success with medical devices and combination products including compliance with the EU Medical Device Regulation (MDR)
Global pharmacovigilance and device vigilance capabilities including appropriate reporting to Competent Authorities in both the development and post-marketing phase