Executive CMC Planning

Fast and reliable Project Planning

Our Executive CMC Plan covers the entire drug development value chain. Activities, deliverables, milestones, dependencies, estimated timelines, estimated costs and more.
Our Executive CMC Plan is the perfect foundation for project planning and Investor Pitches.
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Convincing Investor Pitches.

Successful pitches require an Executive Plan - from today to the next value adding milestones. Ambitious and challenging. Realistic and doable. Detailed enough to be credible, flexible enough to adapt to changes and project progress.

Your Executive Project Plan is the foundation for any pitch, your Executive Project Plan convinces boards or investors to back your project. But how to create one at this early stage? Simple! Start with our Executive CMC plan!

The Executive CMC Plan is the core of every project. CMC triggers or blocks key activities. CMC drives timelines. CMC determines FPFV in clinical trials. CMC is key for reaching your next milestone.

Our Executive CMC Plan is the perfect foundation for project planning and Investor Pitches. Comprehensive and comprehensible project planning, aligning costs, activities and deliverables with value adding milestones – the perfect starting point for Investor Pitches.

Deliver and Support
CMC Milestones Add Value

  • CMC is the backbone of the drug development process.
  • CMC delivers material and immaterial results along the value chain.
  • CMC supports the progress of all other disciplines.


Deliver and Support

In any project, CMC delivers immaterial and material results. Material results might be the API (active pharmaceutical in­gredient) in the required quantity and quality, drug product such as capsules for the use in clinical trials or crucial reports and documents like master batch records, validation reports, INDs or IMPDs. lmmaterial results might be growing process excellence, refined project planning, information about drug product stability or even process related lntellectual Property.

In addition to deliverables, CMC supports all other disciplines, processes or activities on their way towards value adding milestones. Support of Bioanalytics includes information about structures, information about stability of materials or for­mulations, supply of reference standards or supply of deuterium labelled internal standards. Support of Toxicology in­cludes API supply in the required quantity and quality, necessary documentation like CoAs, information on stability and re-testing and analytical methods for necessary "identity testing".

Due to this double role, CMC plays a key role in Executive Planning. Executive Project Plans that are not aligned with CMC deliverables and CMC support are much harder to defend in project pitches. Existing Executive CMC Plans, on the ot­her hands, make Executive Project Planning smooth, reliable and straightforward.

Concrete Example

Let's take API manufacturing as an example. When you start with a new supplier, you can expect about 10 to 20 g of non-compliant API in 6 to 8 weeks, including basic analytical methodo­logy. The next larger amount with 100 to 300 g would be available 10 to 12 weeks later, including better developed analy­tics and first level of GLP compliance, at least for all studies up to a week of experimental run time.

Material sufficient for use in longer term toxicology studies would be available about 4 months later, mainly due to required stability investigations which allow a later re-test date. The same quality and quantity of API, in combination with other CMC deliverables like reference standards and analytical method descriptions, is also sufficient to initiate the development of simple drug products like capsules, including the necessary drug product stability testing. About 12 to 14 months after process start, GMP compliant API batches would be available and could be used for manufacturing of Clinical Trial Medi­cation.

Based on this high-level CMC planning on API supply, major parts of the Executive Project Plan fall automatically into place: earliest start of in vitro toxicology, earliest start of in vivo toxicology, availability of a basic design for clinical phase 1, ear­liest time for FPFV. In short, the outline of an Executive Project Plan. Aligned with CMC, realistic, doable and defendable in a pitch.