merlin pharma offers
Merlin Pharma Consulting Ltd offers services in the field of chemical development of small molecule pharmaceuticals.
Specific areas include:
You have the molecule that you are ready to take forward into toxicology and clinical trials but do you have the right chemistry? Does the synthetic route for medicinal chemistry translate to the best route for large scale manufacturing? Often this is not the case and a new synthetic chemistry route and process needs to be designed to deliver optimal characteristics for scale-up to commercial manufacture.
We can take care of the research and development necessary to find the right balance between cost, speed and the environment while always delivering quality and safety.
When you need more of your drug to progress with non-clinical and clinical studies where do you go to get it made? What is the right timing to scale-up or to introduce the new route you have developed? The answers to these questions are not obvious. They are multi-factorial, strategic questions that require experience and detailed consideration.
We will work with you to find the right strategy for your individual situation. We can help you evaluate and select a preferred contract manufacturing organisation and carry out technical transfer of your process to the chosen CMO.
project management and regulatory
Embarking on the next phase of development with a new project is exciting, but it can also be overwhelming.
We can help you to handle new challenges by managing your contract research and development organisations. We can prepare the technical elements of your CMC regulatory submissions e.g. your IND or IMPD. We can support validation and pre-approval inspection of the process at your CMO.