Medical & Regulatory

Formulation, device and development services are supported by our medical, regulatory, device vigilance & pharmacovigilance teams to advance your programme and ensure the smoothest path to product approval.

Medical

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

Contact us about this service

Other available services

Formulation

Explore our dry powder and liquid formulation capability

See more
Device Platforms

See how our DPI, pMDI and nebuliser technologies can support your novel or generic programme

See more
Process Development & Technical Transfer

Scale-up from laboratory through to commercial scale

See more
Pharmaceutical Analysis

Comprehensive analytical services to characterise inhaled products

See more