Regulatory Services

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

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

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Other available services

Formulation

Explore our dry powder and liquid formulation capability

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Device Platforms

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

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Process Development & Technical Transfer

Scale-up from laboratory through to commercial scale

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Product Manufacturing

See how our in-house manufacturing facilities and equipment can support your programme

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