Combination products (drug-device, biologic-device, drug-biologic) are inherently complex and the regulatory pathway to product approval can be challenging to navigate.

IQS Consulting will help you understand the GMP requirements for combination products and assist with CDMO selection and provide CMC support. Our focus is ensuring 21 CFR Part 4 requirements are understood and embedded in your Quality System whether you are device manufacturer learning about drug GMPs or a drug manufacturer seeking to meet the QS Regulation.  Design controls, purchasing controls and quality risk management principles are thoughtfully considered regardless of the client and program size.  

Service goal: Provide cGMP Assessment and assist with the CMC Roadmap to Commercialization.