Regulatory Strategies for Investigational Products, Medical Devices & Combination Products
We appreciate our clients operate within a tight, complex and ever-changing framework of regulation. As a result, Illingworth Research has become highly skilled in assisting companies to adopt effective and appropriate regulatory strategies for both investigational products and medical devices, as well as combination products, i.e. inhaler.
The regulatory process can be quite intimidating at times we feel with so many elements to consider. If it is not a process you are regularly involved with it is highly challenging with the constant alterations and layers to the process. This is why we offer a helping hand, as much or as little support as you need, our team are regularly involved with regulatory approval and are kept at the forefront of any changes within the process.
In many cases, it can be faster to obtain regulatory approvals for studies in the UK. We have an extensive network of contacts within the UK industry and can put you in touch with the right people for your business. We can help you understand market access, clinical study requirements and study planning both in the UK and Europe.
As with all our services, our approach is flexible and designed to meet the individual needs of our clients and can include:
- Regulatory strategy development
- Clinical, non-clinical and CMC expertise
- Preparation and submission of CTAs/INDs for phases I-IV
- Regulatory agency liaison including meeting preparation and facilitation
- Marketing authorisation applications
- Ethics committee submissions