solutions & expertise
Combination Products
Delivering tailored solutions to our clients in order to unlock regulatory hurdles and help them to meet their goals
Quality Management Systems and Remediation
In the US, combination products need to follow cGMPs per 21 CFR 4.
We offer comprehensive support in the management of quality management system documentation processes to ensure adherence to regulatory requirements and quality standards for combination product manufacturers, ensuring each the appropriate requirements for each constituent part are appropriately addressed.
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 yield a positive impact on public health and the quality of life for patients.
Guiding You Every Step of the Way
- Provide consultancy for combination products, encompassing both device-led and drug-led categories.
- Assist with Quality System/cGMP documentation development for each constituent part of a combination product or the combination product as a whole.
- Assess gaps in Quality System procedures and implementation.
- Review supplier agreements.
- Perform mock audits.
- Provide in-house training on FDA regulatory issues and new policy developments.
- Assist with remediation and resolution of compliance issues including those in a Warning Letter, Untitled Letter, or FDA-483.
Book a Consultantion with an Expert
Interested in working together? We would love to hear from you!