Reference Listed Drug

Arkon Solutions: Your Global Partner in RLD Sourcing

The growth is being fueled by various factors, chief among them being the huge wave of patent expirations of key branded drugs, which presents opportunities for generic substitutes. Further, the increased global incidence of chronic diseases demands affordable treatment alternatives, further enhancing the market for generics. A crucial regulatory step in bringing generic drugs to market involves demonstrating their bioequivalence to an already approved product known as the Reference Listed Drug (RLD). New generic versions are rigorously compared to the RLD to ensure they perform identically within the body.

This is where Arkon Solutions offers you an indispensable service. Expertizing in the worldwide sourcing and supply of RLDs, Arkon Solutions makes certain that businesses are connected with the necessary products for their bioequivalence testing and regulatory approvals. Taking advantage of a great network of proven suppliers in major regions like EU, USA, Canada, South East Asia, China, and Japan, Arkon Solutions is able to procure pharmaceutical products directly and securely, serving the needs of most major pharmaceutical companies worldwide and streamlining a critical phase of generic drug development.

Trusted Across Healthcare

Liable sourcing

Timely Updates

Optimized pricing

Scheduled delivery

Thermal stability

Pre and Post-delivery Support

OUR MAJOR OFFERINGS IN RLD

Sourcing of Innovator Samples

Reference Listed Drugs (RLDs) are essential for pharmaceutical companies to conduct research and development projects, as well as for clinical trials and bioequivalence studies. At our company, we specialize in providing RLD sourcing services to these very organizations, ensuring that they receive well- compliant and validated drugs in a timely, secure and efficient manner.

Well Protected and Safeguarded Logistic Support

We understand the critical importance of correctly handling Reference Listed Drugs (RLDs),encompassing meticulous transportation and storage practices to unfailingly preserve their quality and integrity. Leveraging our safe and secured access to global storage and distribution networks, we manage the entire shipping and distribution process with utmost care and under proper survillence . This enables us to offer customised tailored logistic solutions, designed to meet each client’s unique requirements while consistently ensuring the quality assurance and efficacy of these vital pharmaceutical drugs.

Custom Clearance Support

As a pharmaceutical company Arkon Solutions is deeply entrenched in the complexities of global drug development and supply chains.Our expertise extends significantly into the intricate process of customs clearance, particularly for Reference Listed Drugs (RLDs).

Arkon Solutions have a profound experience with import/export regulations regarding controlled substances, temperature-sensitive commodities, and requisite documentation like Certificates of Analysis (CoA), import authorization, andregulatory clearances as per pharmaceutical formulation.

Licensing Support

At Arkon Solutions we have extensive experience in offering complete licensing assistance specifically designed for the RLD process.
Our expertise goes beyond mere procurement; we are expert strategic sources of genuine RLD lots with special care in handling, proper storage, and detailed documentation needed to comply with strict regulatory requirements.

Seizing on our expansive network and deeper knowledge of the world’s global pharmaceutical supply chain and regulatory guidelines, we process this critical phase for our customers, allowing them to effectively pursue their bioequivalence studies while moving their Abbreviated New Drug Application (ANDA) submissions forward securely, supported by our dependable and compliant RLD services.

Validated Supplier Network

Arkon Health has a team of qualified and specialized Support team to guide you. Our specialists cater to the specific medical needs of the patients and healthcare professionals to ensure tailored solutions.

Why You Should Trust ArkonSolution for Reference Drug Sourcing?

Reference Listed Drug acquisition paradigms

Integrated regulatory strategy and compliance expertise

Robust logistics capabilities

Advanced quality management and assurance systems

Consistent global availability

End-to-end visibility

Risk management and mitigation framework

Frequently Asked Questions

A Reference Listed Drug (RLD) is a specific approved reference medicine used as the benchmark for certain generic drug development and bioequivalence requirements. The appropriate RLD depends on the applicable regulatory pathway, reference product requirements, market, strength, dosage form, and study requirements.

Yes. Arkon Solutions LLP can source Reference Listed Drugs from the US and EU markets, subject to product availability, applicable regulatory requirements, and specific project requirements. We coordinate international sourcing, documentation, import-related requirements, and logistics based on the required RLD.

A Reference Listed Drug can be sourced through specialized pharmaceutical sourcing providers with access to regulated international markets and appropriate supplier networks. Arkon Solutions LLP supports RLD identification, international sourcing, documentation, logistics, and import-related coordination based on the specific product and project requirements.

Reference Listed Drugs may be sourced from appropriate regulated markets depending on the product, regulatory requirements, and study specifications. Arkon Solutions LLP has sourcing capabilities across markets including the USA, Europe, Canada, Japan, Southeast Asia, and other international markets, subject to product availability and applicable requirements.

RLD documentation may include product and batch information, Certificate of Analysis (COA), invoices, product labels, packaging details, expiry information, and relevant traceability or import documentation. The exact documentation required depends on the product, source market, intended use, and applicable regulatory requirements.

Yes, RLDs may be sourced for bioequivalence and BA/BE studies when the selected reference product meets the applicable study and regulatory requirements. The product, strength, dosage form, market of origin, batch information, and documentation should be evaluated against the requirements of the specific study and regulatory pathway.

RLD sourcing can support generic drug development and regulatory activities such as ANDA-related requirements where applicable. Arkon Solutions LLP can assist with identifying and sourcing the required reference product, including coordination of availability, batch information, documentation, international procurement, and logistics.

RLD authenticity can be assessed through the source of procurement, supplier or distributor verification, product and batch information, packaging and labeling, documentation, and available traceability records. Arkon Solutions LLP works with established supplier networks and evaluates sourcing requirements to support product authenticity and traceability.

Yes, temperature-sensitive RLDs can be considered for sourcing with appropriate temperature-controlled logistics. Depending on the product requirements, transportation may involve qualified packaging, temperature monitoring, controlled handling, and coordination throughout the shipment to help maintain required storage conditions.

Arkon Solutions LLP supports end-to-end RLD sourcing by assessing product requirements, identifying suitable international sourcing options, coordinating procurement, reviewing available documentation, supporting import and customs requirements, and coordinating logistics and delivery. Each Reference Listed Drug requirement is evaluated based on the product, market, quantity, study requirements, and applicable regulations.