Our Services

End-to-end solutions for the pharmaceutical lifecycle.

Custom API Manufacturing

From the laboratory bench to the manufacturing floor, our Custom API Synthesis services are designed to accelerate your drug development timeline. We specialize in complex chemistries and multi-step synthesis.

  • Route Scouting & Optimization

    We identify the most efficient synthetic pathways to maximize yield and minimize impurities.

  • Scale-Up & Tech Transfer

    Seamless transition from gram-scale pilot batches to metric-ton commercial production.

  • Commercial Validation

    Rigorous process validation (PPQ) to ensure reproducibility and compliance with GMP standards.

API Synthesis Lab

Regulatory Documentation & Support

Navigating the regulatory landscape is as critical as the chemistry itself. Our dedicated Regulatory Affairs team ensures that your project meets all international compliance standards.

  • DMF Filings

    Preparation and submission of Drug Master Files (DMFs) in CTD format for USFDA, EMA, and other global agencies.

  • Audit Support

    Comprehensive support during USFDA and customer audits, including mock audits and gap analysis.

  • Tech Transfer Packets

    Detailed technology transfer documentation to facilitate smooth site-to-site transfers.

Regulatory Compliance Meeting

Global Sourcing & Logistics

Our roots in logistics give us a competitive edge. We manage the entire supply chain, ensuring that your raw materials and finished products are handled with the utmost care and efficiency.

  • Cold Chain Management

    Specialized logistics for temperature-sensitive compounds, utilizing validated packaging and data loggers.

  • Hazardous Material Handling

    Certified expertise in the transport and storage of hazardous chemicals, fully compliant with IATA and IMDG regulations.

  • Strategic Sourcing

    Access to a global network of audited suppliers for key starting materials (KSMs) and intermediates.

Global Logistics