Innovative partnership between Crystal Pharmatech and TCG GreenChem
Within today's pharmaceutical industry, drug development can be categorized into two approaches:
1. Large, fully integrated pharmaceutical companies using a strategic approach.
Makes the best use of material and mitigates risk
But often hindered by red tape and over-analysis
2. Biotechs and startup drug developers using a trial-and-error approach.
Provides agility and a cost-effective budget
But creates significant risk and uncertainty
The pharmaceutical innovators we encounter are constantly guided down a random walk approach at all stages of drug development. Crystal Pharmatech and TCG GreenChem have developed a unique CMC package that incorporates only the best aspects of both industry approaches.
With M4M™ Lead Op to FIH, our partners can expect a strategic and risk-adverse path from molecule to medicine that is agile and cost-effective.
First Time Right
Single proposal and CDA
Consistent Project Manager
No duplicate analytical development
Best form, formulation, and process chemistry
Line of Sight
CMC mapped from lead op to FIH
Early process chemistry and formulation input
No random development
Real-time API prioritization – best use of every gram at every point in time
An experienced leadership team is a vital for maximizing efficiency and effectiveness in drug development from lead optimization to FIH and eventually commercialization.
Crystal Pharmatech and TCG GreenChem have partnered to bring together centers of excellence in:
API form and formulation
Drug development acceleration
The foundation of these centers of excellence is a leadership team that has already seen and solved every possible challenge a development program can encounter.
API Form and Formulation Service Details
Process R&D and API Manufacturing Details
Early cohesion between industry-leading Process Chemists, Solid State Experts, and Formulation Specialists gives you:
1. Process and Formulation assessment with limited material
Guide candidate selection while establishing Phase I complexity and path
2. Line of sight for API and formulation
Minimize post Phase I delays
Minimize bridging studies due to formulation changes
3. Condensed timelines and resources
No more random walk or dart throwing
No duplication of analytical development
No "wasted or excess" API batches
Personalized formulation, no more one-for-all platform formulations
4. Highly experienced leadership team that can rapidly guide strategy for every project