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CMC – First Time Right with Line of Sight

Innovative partnership between Crystal Pharmatech and TCG GreenChem


An Optimized Approach to Chemistry, Manufacturing, Controls (CMC)

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

Line of Sight


M4M_Lead_Op_to_FIH_-_P2.pngCenters of Excellence

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:

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.


M4M™ Approach – Full CMC Package

API Form and Formulation Service Details

Process R&D and API Manufacturing Details


Our Experience Becomes Your Competitive Advantage

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

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bd_global@crystalpharmatech.com +1-609-604-8303
Suite 500-B, 3000 Eastpark Blvd, Cranbury, New Jersey 08512, USA
6800 Kitimat Rd, Unit 1, Mississauga, Ontario, Canada L5N 5M1
Suite B4-101, Biobay, 218 Xinghu Street, Suzhou Industrial Park, Suzhou, China, 215123
Suite 500-B, 3000 Eastpark Blvd, Cranbury, New Jersey 08512, USA
bd_global@crystalpharmatech.com +1-609-604-8303