CMC Healthcheck - FAQ

Q. What is CMC?

Chemistry, Manufacturing and Controls (CMC) is a term used in the regulatory filing of a new drug – it describes the development activities of the drug substance (active pharmaceutical ingredient or API) and drug product, the way in which both are made and by which the manufacturing process is demonstrated to be in control to regulatory authorities.

Q. Why is CMC overlooked compared with a drug’s clinical phase?

Much of the focus on a drug’s development is focused on its performance in the clinic i.e. where its safety and efficacy are determined. To get any clinical study to work you need a medicine to administer. A medicine for the clinic is only achievable with a good CMC package.

Q. What are the consequences of NOT doing a CMC Healthcheck?

There are numerous technical and procedural hurdles to overcome in both pre-clinical and clinical development, which usually involves considerable resource. All products and processes have technical issues that need to be overcome in order to meet the necessary potency, quality and safety attributes of the medicine. A poor CMC package can stop a drug’s development in its tracks. We help the client adopt a proactive approach to CMC development and circumvent project issues.

Q. What does a CMC Healthcheck review actually entail and mean?
 
A review means different things to different people. The CMC Healthcheck review is a scientific critique and assessment of data. The underlying strategy of synthesis/analysis etc and the validity of the CMC package going forward into scale up, regulatory or clinical trials are assessed. From the review we will identify gaps and potential weaknesses in the CMC package appropriate for the phase of development. A review can be tailored following initial discussion with the client.
 
Q. I only need a process chemistry review - I am happy with my analytical CMC and do not need the full package?
 
Every package is specific to the client. We recognise that only some review elements may be required. We can tailor to suit your needs.
 
Q. What if you find issues - can you help?
 
After the assessment and review we work with our clients to resolve any issues that have been identified.
 
Q. How can you cover all these fields expertly?
 
We are specialists with training in best practice in CMC development gleaned from years of experience spent in big pharma. If in the unlikely scenario we find ourselves out of our-depth, we have access to additional experts that can be pulled in as/when required, assuming the client consents.

Q. How do you set the fee?
 
The fee depends on the complexity of the review which is broadly linked to the length/complexity of the synthetic chemistry used to produce the API. Once agreed, the fee is fixed and the client will not be charged extra. Any additional work resulting from the CMC Healthcheck will be mutually agreed up front and will be subject to an additional contract.