RLD Sourcing Services

Comprehensive comparator supply solutions for clinical trials / bioequivalence studies and regulatory submissions. We provide end-to-end RLD sourcing with full traceability, regulatory compliance, and documentation support across US, EU, and ROW markets.

What We Offer

Reference Listed Drug (RLD) sourcing is critical for generic drug development and clinical trials / bioequivalence studies. Our comprehensive sourcing services ensure you receive authentic, compliant comparator products with complete regulatory documentation.

We specialize in sourcing FDA-approved reference listed drugs, EMA-authorized reference medicinal products, and regional reference products for global markets, all while maintaining strict adherence to Good Distribution Practice (GDP) guidelines.

Comprehensive Comparator Supply Solutions

Key Benefits

Full Traceability

Complete chain of custody documentation from manufacturer to your facility, ensuring authenticity and regulatory compliance at every step.

GDP Compliance

All products sourced and distributed in accordance with Good Distribution Practice guidelines, with Swissmedic GDP license #512189-102657423.

Regulatory Documentation

Comprehensive documentation packages including Certificates of Analysis, Certificates of Conformity, import permits, and regulatory letters.

Temperature Control

Specialized cold chain management ensuring products maintain required storage conditions throughout transportation and handling.

Global Reach

Sourcing capabilities across US, EU, and ROW markets, with expertise in navigating regional regulatory requirements.

Time Efficiency

Streamlined processes and established supplier networks to minimize lead times and ensure timely delivery for your studies.

End-to-End Process

From initial request to final delivery, we manage every aspect of RLD sourcing with precision and attention to detail.

End-to-End Process From Request to Delivery
  1. Request & Assessment

    We receive your RLD requirements and conduct a comprehensive assessment of product availability, regulatory status, and sourcing options. This includes verification of reference product designation and identification of authorized suppliers.

  2. Supplier Qualification & Sourcing

    Our qualified supplier network is leveraged to source authentic products directly from authorized distributors or manufacturers. All suppliers are pre-qualified and regularly audited for GDP compliance.

  3. Documentation & Compliance

    We prepare comprehensive regulatory documentation packages, including Certificates of Analysis, Certificates of Conformity, import/export permits, and any required regulatory letters. All documentation is verified for accuracy and completeness.

  4. Quality Assurance & Verification

    Products undergo authenticity verification and quality checks. We ensure proper labeling, packaging integrity, and compliance with storage requirements before shipment.

  5. Shipping & Delivery

    Temperature-controlled shipping is arranged with real-time monitoring. We provide tracking information and ensure proper handling throughout transit. Upon delivery, we confirm receipt and storage conditions.

  6. Post-Delivery Support

    We provide ongoing support including storage guidance, documentation for regulatory submissions, and assistance with any compliance-related inquiries.

Compliance & Documentation Highlights

Regulatory Compliance

  • GDP Compliance: All operations conducted in accordance with EU GDP guidelines and Swissmedic requirements
  • Swissmedic License: Valid GDP license #512189-102657423 for pharmaceutical distribution
  • FDA Compliance: Sourcing of FDA-approved reference listed drugs with proper documentation
  • EMA Compliance: Access to EMA-authorized reference medicinal products
  • Anti-Counterfeiting: Rigorous authenticity verification processes

Documentation Package

  • Certificate of Analysis (CoA) from manufacturer
  • Certificate of Conformity (CoC) for GDP compliance
  • Import/Export permits and customs documentation
  • Regulatory letters and authorization documents
  • Chain of custody documentation
  • Shipping and handling records
  • Temperature monitoring records (where applicable)
  • Storage and handling instructions

Use Cases & Engagement Models

Bioequivalence Studies

Sourcing of reference products for clinical trials / bioequivalence studies required for ANDA submissions and generic drug approvals.

Regulatory Submissions

Providing comparator products with complete documentation for regulatory dossier preparation and submission.

Analytical Method Development

Supply of reference standards for analytical method development and validation activities.

Formulation Development

Comparator products for reverse engineering and formulation development studies.

Stability Studies

Reference products for comparative stability studies and shelf-life determination.

Clinical Trials

Sourcing of active comparator products for clinical trial requirements.

Related Solutions

Tie comparator sourcing to downstream transfer, licensing, and launch execution.

Technology Transfer

Convert RLD learning into validated commercial processes with EUCTD / CTD-ready documentation.

View Service

Strategic Partnerships

Leverage verified comparator data to structure licensing, market entry, and co-development deals.

View Service

Talk to Our Team

Book a working session to map supply scenarios, risk controls, and compliance deliverables.

Contact Us

Frequently Asked Questions

  • What is the typical lead time for RLD sourcing?

    Lead times vary depending on product availability, regulatory requirements, and destination. Typically, standard products can be sourced within 4-8 weeks, while specialized or regulated products may require 8-12 weeks. We provide detailed timelines during the initial assessment phase.

  • How do you ensure product authenticity?

    We source products exclusively from authorized distributors and manufacturers. All products undergo authenticity verification, including batch number verification, packaging inspection, and documentation review. We maintain a strict supplier qualification process and conduct regular audits.

  • What documentation is included with RLD shipments?

    Each shipment includes a comprehensive documentation package: Certificate of Analysis, Certificate of Conformity, import/export permits, regulatory letters, chain of custody documentation, shipping records, and temperature monitoring data (where applicable). All documentation is prepared in accordance with regulatory requirements.

  • Do you handle temperature-sensitive products?

    Yes, we specialize in cold chain management for temperature-sensitive products. We use validated shipping containers, real-time temperature monitoring, and ensure proper storage conditions throughout the supply chain. All temperature records are provided with delivery.

  • Can you source products for multiple countries?

    Absolutely. We have sourcing capabilities across US, EU, and ROW markets. We can coordinate multi-country sourcing projects and ensure compliance with regional regulatory requirements. Our team has expertise in navigating different regulatory frameworks and import/export procedures.

Ready to Source Your RLD Requirements?

Speak with our team to discuss your comparator sourcing needs and discover how we can support your clinical trials / bioequivalence studies and regulatory submissions.

Contact Us Explore All Services