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Drug Development Knowledge and Know-how at your fingertips...

Training courses on Drug Development and CMC

CMC is the aspect of MAKING drugs  and biologicals at pharmaceutical quality standards, in compliance with GMP and other regulations

Free on-demand mini-course

The Journey of Drug Development

Quickly understand the main moving parts of Drug Development:

Enroll for free:

  • The clinical phases

  • Drug manufacturing and CMC

  • The regulatory framework

  • Career paths in Pharma

Ideal for those that just need a quick orientation to the main pillars of the field- no prior knowledge assumed.

Students, young-professionals, and experienced professionals from other fields- this one is for you!

Seasoned professionals in Pharma- send this to your junior teams and colleagues who might find it useful.

 

On-demand mini course 

The Full Story of CMC (a.k.a CTD Module 3)

Learn the high level picture of CMC:

  • The Regulatory-CMC Framework and ICH Guidelines

  • Product modalities and the QTPP

  • Manufacturing development, GMP and CDMOs

  • Quality Assurance, Quality Controls and Quality By Design

Ideal for those that need a quick (yet comprehensive) overview of Drug Manufacturing at Pharmaceutical Standards, a.k.a CMC
 
CEOs, Project managers, Business Development, Quality professionals - this one is for you!

On-demand OR Live: Deep dive, 10 weeks course

The CMC Essentials Training course

Deep dive introduction to CMC Development:

  • Speak the language of CMC with your team, service providers and Regulatory Authorities

  • Fully understand the regulatory framework and relevant guidelines

  • Reduce development risks and apply the principles of QBD and Phase-appropriate GMP

Ideal for those that need a full orientation to properly operate within the realms of CMC development.
CMC Project managers, CMC- QA, RA-CMC professionals - this one is for you!
The course is available both on-demand and in live cohorts, several times a year.

All Beyond CMC Students are invited to
The Tree Club
Our weekly live meeting for Q&A and discussions on real-life situations

Coming soon....

CTD Module 3 Hands-on workshop

Create your own working copy of the Quality (CMC) sections of an IND / IMPD

In a laser focused, 8-weeks workshop, we will create together your first version (or update) of the CTD Module 3- which is the standard format for the Quality (CMC) sections of all regulatory submissions (IND/IMPD/NDA/BLA) 

Ideal for:

  • Early phase / preclinical startups that can't afford expensive regulatory consultants/agencies to write their Module 3, but want to advance their regulatory portoflio and save time/money later on

  • Regulatory teams that need help training junior staff on CMC in general and Module 3 writing

Don't wait until submission is on the critical path- populating your Module 3 since day 1 of the project is a powerful tool for knowledge management and guiding your CMC Development efforts.

Start today in house- outsource just the final touch, later...

Online School
Services

Need help with your Regulatory/CMC challenges?

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