Explore Our Services

CRO

Contract Research Organization - APIs & Intermediates

From Molecule to Method — Focused R&D for Scalable Success

  • Route Scouting & Process Research Identification and optimization of cost-effective, scalable synthetic pathways for APIs and intermediates.
  • Analytical Method Development Comprehensive characterization and method validation for regulatory and quality compliance.
  • Impurity Profiling & Stability Studies Identification, isolation, and control of impurities for regulatory submissions.
  • FTE (Full-Time Equivalent) Dedicated scientists work exclusively on your projects, ensuring continuity, confidentiality, and seamless communication—ideal for long-term or evolving research programs.
  • FFS (Fee-for-Service) Project-based support for defined tasks with clear deliverables, rapid execution, and cost-effective pricing—perfect for short-term or specialized requirements.
CRAMS

Contract Research & Manufacturing Services

Custom Chemical Synthesis for Pharma and Beyond

  • Custom Development Projects End-to-end project execution from R&D to pilot-scale manufacturing.
  • Intermediates & Niche API Production Robust and reliable synthesis under confidentiality agreements.
  • Regulatory Support Supporting documentation for client filings in global markets.
CDMO

Contract Development and Manufacturing Organization

Scaling with Precision - Commercial Manufacturing Solutions

  • Non-GMP to cGMP Scale-up Pilot, kilo lab, and commercial scale-up capabilities for regulated markets.
  • Technology Transfer & Process Optimization Seamless process transfer and cost reduction strategies.
  • Regulatory Filing Support Assistance in USDMF, EDMF, and CEP documentation and submissions.
CMC

Chemistry, Manufacturing & Controls

Ensuring Data Integrity from Lab to Launch
At Terazed Life Sciences, our CMC services bridge the gap between discovery and commercial readiness. We focus on generating high-quality, submission-ready data for regulatory agencies and building a strong technical foundation for manufacturing.

  • CMC Documentation: Preparation of detailed CMC sections for regulatory submissions, including pharmaceutical development, control of materials, and process validation data.
  • Stability Protocols & Storage Studies: Real-time and accelerated stability testing under ICH conditions with thorough data analysis.
  • Comparability & Change Management: Assessment and documentation support for manufacturing changes, scale-up batches, and site transfers.

This service ensures technical accuracy and regulatory robustness throughout your product's lifecycle.

Regulatory Filings Support

Accelerating Market Access with Regulatory Precision
Our regulatory affairs experts provide hands-on support to streamline your global submission strategies. This service stands apart from CRAMS by focusing solely on regulatory documentation and compliance, not development execution.

  • Regulatory Roadmapping: Assistance in defining submission pathways across the US FDA, EMA, DCGI, PMDA, and other agencies.
  • Dossier Writing & Compilation: CTD/eCTD-ready modules for APIs, intermediates, and excipients, designed for seamless integration with your existing documentation.
  • Lifecycle Management: Support with variations, renewals, deficiency responses, and pre-approval queries.

Custom Synthesis

Precision Chemistry for Strategic Needs
We offer dedicated synthesis services for rare, complex, or unavailable molecules. Unlike general manufacturing, our custom synthesis service focuses on:

  • Targeted Molecule Development: Ideal for early-stage discovery, reference standards, and impurities that are not commercially available.
  • Milligram to Multi-Kilo Batches: Rapid scale flexibility for development-stage programs.
  • Confidential Research Partnerships: We work closely with your R&D teams while maintaining strict IP and data security protocols.

Whether you’re solving a formulation challenge or validating a new synthetic route, our custom synthesis capabilities deliver tailored solutions with scientific rigor.