Services

1. FTE – Full-Time Equivalent

Definition:
FTE refers to a dedicated scientific resource (chemist, biologist, analyst, etc.) allocated full-time to a client’s project.

Key Features:

• Resources work exclusively on the client’s tasks.
• Offers flexibility in prioritizing and adjusting project goals dynamically.
• Ideal for long-term, complex projects where scope evolves over time.
• Enables seamless integration of client and CRO teams.

Benefits:

• Direct control and communication with the team.
• High confidentiality and continuity.
• Efficient knowledge transfer and collaboration.

2. FFS – Fee-for-Service

Definition:
FFS is a pay-per-task model where the client pays a fixed fee for specific services or deliverables.

Key Features:

• Services are clearly defined and priced upfront (e.g., synthesis of X number of compounds, ADME testing, etc.).
• Suitable for short-term or well-defined tasks.

Benefits:

• Cost transparency and predictability.
• No long-term commitment.
• Quick turnaround for individual or stand-alone tasks.

At the core of our operations lies custom synthesis of complex organic molecules—a domain where our scientific expertise and research experience consistently deliver results with speed and precision. We provide high-quality, scalable solutions tailored to your development needs, from early discovery to large-scale production.

We provide high-purity, well-characterized reference standards essential for regulatory filings, quality control, and analytical method validation. These standards support accurate identification, quantification, and qualification of active pharmaceutical ingredients (APIs), impurities, and degradation products in both development and commercial stages.

Our team synthesizes stable isotope-labeled compounds (²H, ¹³C, ¹⁵N) tailored for ADME (Absorption, Distribution, Metabolism, and Excretion) studies, bioanalytical quantification, and mechanistic investigations. These compounds are critical tools in pharmacokinetics, metabolic pathway elucidation, and internal standard development for LC-MS/MS assays.

We specialize in the custom synthesis of phase I and phase II drug metabolites, including glucuronides and sulfates. These reference materials are indispensable in DMPK studies, toxicological assessments, and regulatory submissions to demonstrate metabolite safety and ensure proper bioanalytical coverage.

Our capabilities include isolation, characterization, and structural elucidation of process-related and degradation impurities using advanced analytical techniques such as NMR, MS, LC-MS, and HRMS. This service supports impurity identification as per ICH guidelines, ensuring compliance and risk mitigation.

We conduct in silico predictive evaluations of potential genotoxic impurities (PGIs) using state-of-the-art computational toxicology platforms. These assessments align with ICH M7 guidelines and help in identifying structural alerts early in the development process to avoid costly redesigns.

We offer custom synthesis of challenging impurities, including regulatory critical or low-level genotoxic compounds, often required in trace quantities. Our expertise ensures accurate impurity reference materials for method validation, toxicological studies, and impurity fate tracking.