Process, Analytical Research, Development & Demonstration of Scalability

Process, Analytical Research, Development & Demonstration of Scalability

Service Image

TCG Lifesciences provides integrated process and analytical R&D services with comprehensive CMC support to develop safe, scalable, and robust manufacturing processes. Initial scale-up is demonstrated in our Kolkata-based non-GMP kilo lab, followed by seamless technology transfer to our subsidiary TCG GreenChem Manufacturing for GMP manufacturing and commercial campaigns. 

We support programs from early laboratory-scale development through clinical and commercial manufacturing, serving pharmaceutical, animal health, and specialty chemical companies across the United States, European Union, Japan, India, and other global markets.

Show more

Key services

Icon
Process, analytical & manufacturing services

Icon
Specialized capabilities

Icon
Process development & technology transfer

Icon
Kilo laboratory capabilities- demonstration of scalability

Icon
Analytical validation services (US-FDA inspected facility)

  • Integrated capabilities across chemistry, analytical, process development, and engineering
  • Systematic process development to advance molecules from laboratory scale through clinical and commercial manufacturing, enabling the development of robust, safe, sustainable, and cost-efficient processes 
  • Expertise in route scouting, process optimization, and demonstration of scalability
  • Technology transfer support for process validation and commercial manufacturing
  • Proven expertise in scaling complex and chiral chemistries while maintaining quality and timelines

  • Advanced R&D facilities for innovative synthetic methodologies
  • Kilo lab for pilot-scale simulation and scalability demonstration
  • Safety and risk assessment using DSC, RC studies, and QRA prior to scale-up
  • Specialized equipment including parallel reactors, Parr hydrogenators, autoclaves, and low-temperature reactors
  • Dedicated hydrogenation facility
  • Integrated operations with synthesis and analytical capabilities under one roof

Why TCGLS CMC is the preferred partner?

  • Experienced CMC team with expertise in drug substance development aligned with global regulatory expectations

  • An experienced supply chain team with global sourcing capabilities, adept at identifying qualified suppliers worldwide while also developing reliable local suppliers in India through established networks—supporting resilient, cost-efficient, and sustainable supply chains

  • Structured project management with transparent communication and milestone tracking for QOTIF (quality on time in full) delivery

  • Well-equipped analytical team supporting method development, validation, and stability studies with high data integrity

  • Proven experience advancing programs from lab development to clinical stages and supporting IND submissions

  • Flexible, collaborative approach aligned with program timelines, budgets, and strategic goals

Business Enquiry