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Custom Synthesis Services

Comprehensive Custom Synthesis Portfolio
Pharmaceutical Impurities & Reference Standards

We specialize in the custom synthesis, isolation, and qualification of pharmaceutical impurities and reference standards required for regulatory submissions and quality control.

Services include:

  • Pharmaceutical impurity reference standards
  • Custom synthesis of impurities (mg to gram scale)
  • Process-related impurities & degradation products
  • Pharmacopoeial & non-pharmacopoeial standards
  • (EP, USP, BP & IP)
  • System suitability materials as per pharmacopoeial methods
  • Traceable working standards for routine QC use
  • Isolation and purification of impurities from APIs and finished drug products

All standards are supplied with full characterization, COA, and regulatory-compliant documentation.

Custom & Complex Molecule Synthesis

Our chemists possess extensive experience in challenging and multi-step synthetic chemistry, enabling us to deliver complex and high-value molecules with consistent quality.

Capabilities include:

  • Custom synthesis of complex organic molecules
  • Stable isotope-labelled compounds
  • Drug metabolites, photochemical compounds & glucuronides
  • Targeted synthesis of known and novel molecular entities
  • Food & beverage analytical standards
  • Specialized chemistry support for R&D and regulatory needs
Impurity Isolation, Characterization & Stability Support

We provide advanced solutions for impurity identification, enrichment, and structural confirmation, critical for regulatory compliance and process understanding.

Key offerings:

  • Pharmaceutical impurities from mg to gram scale
  • Isolation, purification, and enrichment of known and unknown impurities
  • Structure elucidation using advanced spectroscopic techniques
  • Support for forced degradation and stability studies
  • Detailed impurity profiling to support ICH and global regulatory guidelines
API Route Scouting & Process Development

Globesynth Pharma Tech supports clients throughout the API development lifecycle, from route selection to scalable manufacturing processes.

Our expertise includes:

  • API route scouting and feasibility evaluation
  • Synthetic route selection with cost, safety, and scalability considerations
  • Process development and optimization
  • Yield improvement and impurity minimization
  • Scale-up from milligram to kilogram quantities
  • Technology transfer support for pilot and commercial manufacturing
Genotoxic Impurities & NDDS Support

We offer specialized services for genotoxic impurity evaluation and control, aligned with current regulatory expectations.

Services include:

  • Computational evaluation of genotoxic impurities
  • Custom synthesis of genotoxic impurity standards
  • Risk assessment and impurity control strategies
  • Support for New NDDS molecules
  • Documentation aligned with global regulatory submissions
Contract Research & Manufacturing Services

We provide flexible contract research and manufacturing support, helping clients accelerate development timelines while controlling costs.

Capabilities include:

  • Contract research services for custom chemistry programs
  • Large-scale API intermediates & fine chemicals
  • API products from milligram to kilogram quantities
  • Bulk quantity supply for:
    • Toxicity and preclinical studies
    • Product development programs
    • Commercial manufacturing requirements
  • Support through in-house and third-party GMP & GLP-compliant facilities
Quality, Compliance & Confidentiality
  • Robust quality management systems
  • Full analytical support and regulatory-ready documentation
  • Stringent confidentiality and IP protection
  • Transparent project communication and milestone tracking

Why Globesynth Pharma Tech?

  • 28+ years of proven scientific expertise
  • Deep specialization in complex and high-risk chemistries
  • End-to-end synthesis solutions from discovery to commercialization
  • Strong focus on regulatory compliance and data integrity
  • Reliable, confidential, and customer-centric execution
  • Trusted partner for global pharmaceutical innovators and manufacturers