solutions & expertise
Combination Products
Delivering tailored solutions to our clients in order to unlock regulatory hurdles and help them to meet their goals
FDA Submissions
Our team excels at managing or assisting our clients with the preparation of submissions, ensuring they meet regulatory submission requirements, and include all required information for health authorities.
Our company integrates innovative approaches, world-class scientific principles, regulatory proficiency, and a committed team to deliver combination product regulatory design and development solutions that help to advance regulatory science and yield a positive impact on public health and the quality of life for patients.
Guiding You Every Step of the Way
- Prepare or assist in the preparation of regulatory submission for both drug-led and device-led combination products
- Assist clients with the development of device testing protocols and interpreting results
- Assist clients with understanding CMC, non-clinical toxicology, and clinical study requirements
- Provide clients with a comprehensive “FDA style” review of submissions
- Assist with responding to FDA CRL letters
Book a Consultantion with an Expert
Interested in working together? We would love to hear from you!