RegDev’s Regulatory CMC consultants provide strategic guidance to teams, helping them interpret and implement the guidelines of the Health Authority in their respective countries, and guiding them in the preparation and maintenance of required Health Authority documentation (such as INDs, IMPDs, NDAs, BLAs). We are proactive in identifying any CMC-related risks or issues and design and implement appropriate regulatory strategies to address them.
Our Approach
Planning out Regulatory CMC strategy early in development is very beneficial to creating efficient processes. Our skilled consultants are experts in Regulatory CMC and can help our clients avoid many of the pitfalls of this process. We partner with you to plan out winning strategies, tailored to your needs. Our experience allows us to work faster and more efficiently — getting it done right the first time – which ultimately saves you time and allows you to control costs better.
RegDev consultants possess a breadth and depth of experience in Regulatory Chemistry, Manufacturing, and Controls (CMC) and are also seasoned subject matter experts. They provide solid guidance to our clients because they have worked not only in the Regulatory space but, in many cases, directly in the laboratory and in drug development. This deep experience allows our team to anticipate obstacles and work proactively to implement successful strategies for how to approach the Regulatory CMC process.
COMPLETE DATA PACKAGE
REGULATORY REQUIREMENTS
INFORMATION STAGING
INTERPRET AND IMPLEMENT
FILING GUIDANCE
PROCESS STRATEGY
INTERPRET, IMPLEMENT, PREPARE, AND MAINTAIN
Our consultants partner with our clients to interpret and implement the Health Authority guidelines and guide them in the preparation and maintenance of Health Authority documentation. We help teams proactively identify CMC-related issues and regulatory-CMC risks and assist in designing and implementing appropriate regulatory strategies to mitigate risk.
INFORMATION STAGING IS CRUCIAL
Regulatory CMC strategy is ideally planned for early in the Drug Development Lifecycle. Regulatory documents (e.g., INDs, IMPDs) containing more information than required creates a regulatory burden — while not supplying sufficient information can can cause delays. Knowing how to stage information in the documentation is essential to streamlining the development program and creating efficiency.
WINNING STRATEGIES
Planning out the Regulatory CMC strategy early in development is very beneficial to creating efficient processes – and saving time and money. RegDev’s consultants are forward-thinking subject matter experts, with direct regulatory, laboratory, and drug development experience. We partner with you to develop proactive strategies for a more efficient regulatory process.
Team Member Insight
“ Even after a product is approved, CMC changes will often still be required or desired by a company. RegCMC can work closely with the technical team even after approval to build a solid, defensible supplemental NDA/BLA package that is approvable and assures the health authorities that manufacturing continues to be under control and that quality product continues to be produced.”
