Reference List 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

The RLD is typically the first version of a drug approved by the regulatory agency and is officially listed as a reference point which undergoes extensive clinical trials to establish its safety and efficacy. The importance of RLDs are multifaceted such as facilitating generic drug approvals, comparing therapeutic equivalence, driving cost savings, fostering drug quality and standards providing market exclusivity for innovators.

Yes, we acquire our reference listed medicines from countries like the USA, Europe, Japan, and Australia. We follow regulatory guidance and standards and remain compliant with the requirements outlined in the regulations to promote the safety, and legitimacy of the products we distribute.

Yes, Arkon Solution assists RLD suppliers with regulatory affairs. Our team is composed of professionals well-versed in legal pharmaceutical standards, and we consider submitting the documents like Certificate of Analysis (COA) to the patients to understand the quality assurance of the drug.

At Arkon solutions, we procure RLDs only from licensed pharmacies and authorized distributors within regulated markets.

Yes, we manage end-to-end temperature-controlled logistics under rigorously validated cold-chain conditions ensuring strict conformance with all compliance and regulatory frameworks.

Yes, we support single-unit and bulk quantity orders based on project requirements.