Operational CMC Planning
Roadmap to Project Value
Operational Planning is the complete roadmap to your next value adding milestone. Just press START.
Just Press START!
Operational Planning is Executive Planning with added details? Well, not really. Add nothing but details to an Executive Plan, press START and see what happens. Operational Planning is far more than added details. Supplier selection, contracts, logistics, starting materials, manufacturing slots, price tags. Quality, testing, specifications, auditing. Timing, deliverables, dependencies. Data, documentation, reporting, archiving. Operational Planning covers every single activity from start to finish.
Our Operational Plans - your complete roadmap to your next value adding milestones. Just press START.
Attention to Details
- Every single activity
- Fully integrated
- Realistic timelines
- Reliable cost estimates
- Just press START
Herding Cats
Well, getting CROs and CDMOs aligned with operational planning is not as challenging as herding cats but it does come close. Better to enter this part of the process with some clear ideas about requirements and pitfalls.Important parts of the exercise start internally. By outlining the work to be done. By listing topics that are important. Should such an excise result in a wish-list containing scientific excellence and broad range of services, speed and precision, flexibility and adherence to plans, low price and high quality, low cost geographic and ease of logistics, it might be a good idea to reconsider.
While these attributes are not totally contradicting each other, selecting one frequently creates challenges with another. Selecting the cheapest bidder increases the risk for quality issues and deficiencies in science. Going to Asia will have a negative impact on logistics - unless your company is Asian based as well. Better start by defining what will be critical, important and nice to have. Or by assessing the other way around - what would be the impact of NOT having a certain attribute on board. And based on the insight gained there, select your CRO or CDMO partner.
Contracts is also an early part of the exercise. Some are fairly obvious - you need a CDA or NDA before discussing project details with a potential partner. MSAs should be obvious as well but are postponed frequently - only to find later that lawyers on both sides locked horns over some legal details, prolonging MSA signature and project progress in a single go.
Less prominent but also important are other legal documents, like logistics agreement or quality agreements. How is a manufactured product stored, how is access regulated, how will it be shipped, is sub-sampling possible and so on.
Last but not least - allow for some buffers. Even the best laid plan will suffer setbacks and without some intelligently placed buffers, even the smallest loss of time jeopardizes the entire project.
With all of that done - time to press START. And time to move on to the next adventure, keeping dozens of balls in the air without dropping any. For more on that have a look at CMC Monitoring and CMC Management.