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  • About Us
    • Who we are
    • Our Vision and Mission
    • Value Proposition
    • Leadership
      • Board of Directors
      • Leadership Team
    • Scientific Acumen
      • Patents & Publications
      • Research
      • Collaborations
    • Core Competencies
    • Intellectual Property Management
    • Environment Health and Safety
    • Media
      • News Room
  • Our Services
    • Process Research & Development
    • Pharmaceutical Solid State Physicochemical Characterization and Crystallization Development
    • Analytical R&D and Quality Control
    • Analytical Method Validation US FDA Certified
    • Automated Reaction Design and Engineering Lab (ARDEL) and Services
    • Library of Ligands Screening & Development
    • Flow Chemistry Technology
    • Drug Product Development
    • cGMP API Manufacturing
    • US FDA Approved API Manufacturing Facility
  • Capabilities for Innovation
    • CMC Development for Pharmaceutical Research and Development
    • ARDEL (Automated Reaction Design & Engineering Lab)
    • CFL (Continous Flow Technology Lab)
    • From Lab To Manufacturing
    • Scale Up and Cost Effective Manufacturing Options From India (USFDA Facility)
    • Comprehensive Research & Development Capabilities and Services: From Mg to cGMP Commercialization
  • Infrastructure and Facilities
  • Career Opportunities
    • Working with us
    • Current Openings
  • Contact Us

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Process Research & Development
Pharmaceutical Solid State Physicochemical Characterization and Crystallization Development
Analytical R&D and Quality Control
Analytical Method Validation US FDA Certified
Automated Reaction Design and Engineering Lab (ARDEL)
Library of Ligands Screening & Development
Flow Chemistry Technology
Drug Product Development
cGMP API Manufacturing
US FDA Approved API Manufacturing Facilities

Contact Us

TCG GreenChem, Inc. Process R&D Center at Princeton South 701 Charles Ewing BoulevardEwing, New Jersey 08628

TCG GreenChem, Inc. Innovation Center

737 North 5th Street,

Richmond, VA 23219

E-mail: tcggc.customerservice@tcggreenchem.com

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India Development Services

Scale Up Services
  • Rapid Scale-up of Medicinal Chemistry Routes and Identification of Novel Route of Synthesis for APIs
  • Rapid Scale-up to Pre-clinical and IND Toxicology Studies
  • Impurities, Intermediates, and Starting Material Preparation
HAZOP and Process R&D
  • Calorimetry Studies (RC & DSC) to Determine Reaction Scalability and Complete a Hazard Assessment
  • Evaluate Key Parameters for Vessel Design (MOC, Agitation, etc.)
  • New Route Scouting and Process Development
  • Raw Materials Selection
  • Scalability Assessment
  • Solution Stability and Hold Time Studies

Analytical Services for Chemical Development

  • TCG Lifesciences offers a comprehensive array of “Analytical Method Validation” and related studies for global regulatory submissions
  • Laboratory infrastructure includes a full array of analytical instrumentation meeting the 21 CFR part 11 requirements (DUNS # 651030913)
  • Development and validation of analytical methods for both drug substances and drug products as per the current pharmacopeia (USP, BP, EP, JP) or customer specified procedures and specification
  • Impurity identification and isolation by preparative HPLC and SFC
  • Characterization using 1H, 13 C NMR, LCMS, IR etc.
  • Well equipped laboratory to handle high potency drugs
  • Qualified and well-trained team to carry out the analytical study filings to USA, Europe, Japan and other countries

US FDA Approved API Manufacturing Facility

Manufacturing Services include:
  • Manufacture of advanced intermediates and Regulatory Starting Materials (RSMs)
  • Process optimization and validation
  • Custom manufacturing of New Chemical Entities (NCEs)
  • Tech Transfer of existing technologies
  • Commercial manufacturing of API for commercial launch and routine supply

TCG Lifesciences embraces scientific excellence and our reputation of quality and professionalism to our manufacturing services

Analytical Method Validation US FDA/NABL Certified

Analytical Method Development:
  • Raw Material & Intermediate Release
  • API and Drug Product Release
  • ICH Stability Studies
In-process testing method development for reaction monitoring
Phase-based Approach to Analytical Method Qualification & Validation as per US FDA
  • Assay
  • Related substances
  • Residual solvents
  • Forced Degradation Studies
API Release Testing and Certificate of Analysis
Impurity Isolation and Characterization
Reference Standards Certification and Management
ICH Stability Studies for API and Finished Product to support development, clinical study, and commercial manufacturing