Our company ensures the safety and efficacy of pharmaceutical products through rigorous adherence to global regulatory standards. This includes meticulous vendor qualification for Reference Listed Drugs (RLD), thorough New Product Program planning (NPP) involving risk assessments and formulation studies for imported products, and stringent internal controls throughout the Warehouse & Logistics Distribution (WLD) process. We prioritize GMP compliance, robust quality control testing at each stage, and comprehensive pharmacovigilance programs to monitor product performance post-market launch, ensuring patient safety and therapeutic effectiveness .

To ensure regulatory compliance for our service company involved in Reference Listed Drugs (RLD) import and Wholesale Distribution (WLD), we implement a multi-faceted approach.We stick to Good Distribution Practices (GDP) often train our staff on compliance rules, and do thorough checks of how we work. We also maintain close communication with regulatory authorities, ensuring timely updates on legal requirements. On top of that, we create strong standard operating procedures (SOPs) to match what the industry expects.

Our system is well-designed to distribute pharmaceuticals, employing validated temperature controlled packaging. All staff members are trained in handling and transporting pharmaceuticals. We established Good Distribution Practices for the transition process between the distribution chain, and established to ensure a secure chain of custody to prevent diversion or unauthorized access to the pharmaceuticals. Furthermore, we execute systematic risk assessments to identify deficiencies and address any identified risks. All of these methods protect the integrity of the product, ensure storage requirements, protect against damage, adulteration, and loss in the distribution chain.

By following a multi-faceted approach. Comprehensive SOPs- Have Standard Operating Procedures in place and detailed all regulatory requirements for the various activities (import, storage, and distribution). Trained Staff- Have trained personnel with knowledge of the local and international regulations (e.g., GDP, GMP). Due Diligence- Ensure a thorough due diligence of suppliers and customers to prevent counterfeit drugs from entering the supply chain. Traceability- Keep detailed records for full product traceability, allowing for faster recall if needed. Audits and Training- Conduct internal audits regularly and training on a continuing basis to ensure compliance with SOPs and new or updated regulations.

We take great care to verify the quality and effectiveness of all imported RLDs through an elaborate verification process. This process includes an in depth review of the supporting documents and confirming the manufacturer’s compliance with the applicable regulatory requirements (e.g., FDA, EMA). When the RLD arrives, we will batch test each imported RLD to verify its identity, potency, and purity. We will keep precise and complete records of where we source, how we transport, and how we store the RLD to ensure the cold chain is not compromised, resulting in degradation of the RLD. We have verified through the routine monitoring of adverse event reports and pharmacovigilance reports and feedback that we receive when the quality of the product is compromised and can take action promptly.

For Name Patient Programs (NPP), patient assistance involves: Continuous discussion and monitoring from Patient Support Team Comprehensive Education: Education includes an easy-to-understand discussion regarding their condition, the medication being imported, how to take the medication, and possible side effects of the medication. Adherence Support: Adherence support includes medication tools, refill reminders, and tracking medications to improve adherence to the medication. Navigation Support: Navigation support means educating and walking a patient through the import process, paperwork, or required documentation; essentially lowering the burden to get the needed medication supplied and help ensure compliance with the meds. These components promote engaged patients who are empowered to engage as good stewards when managing their treatment through the NPP.

Having reliable 24/7 support of name patient program import, wholesale distribution, and RLD access is never a one-dimensional method. We use a variety of options to provide the best support. For instance, we use one or more of the following options below: Emergency Contact Procedures: We have a dedicated, tiered contact list to maximize immediate connectivity with key leadership personnel for critical issues outside normal business hours. Monitored Voicemail & Email Boxes: Available 24/7, our voicemail and inboxes are monitored and have guaranteed response times according to urgency. Written or Video FAQs & Online Resource Library: A robust online knowledge base that answers most standard questions, and allows for self-service on some issues or requests. Partnering: Teaming with vendors and logistics companies who offer support with extended hours capabilities.