Regulatory and Specialty Services
340B Drug Pricing Program
At ACW Canterlilly, we understand the critical need for maximizing cost savings within the 340B program while ensuring compliance with regulations. Our team of experts is dedicated to assisting organizations in 340B program optimization, thereby ensuring that no cost savings opportunities are missed. By leveraging our in-depth knowledge and experience, we can help streamline processes, identify potential savings opportunities, and implement best practices to maximize the program's benefits. Moreover, we are well-equipped to provide comprehensive assistance in 340B audit preparation, ensuring that our clients are fully prepared for audits and compliance requirements. With our support, organizations can navigate the complexities of the 340B program with confidence, knowing that they are maximizing cost savings and maintaining compliance.
USP 797/800
At ACW Canterlilly, we understand the importance of staying compliant with the latest regulations, especially when it comes to USP 797 and 800. With the new regulations aiming to ensure the safe handling of hazardous drugs and maintain the integrity of compounded sterile preparations, it's crucial for facilities to pivot quickly to meet these standards. Our team at ACW is well-equipped to guide your facility through this transition, offering comprehensive solutions and expert support. From assessing current practices to implementing necessary changes and providing training, we are committed to helping your facility achieve and maintain compliance with USP 797 and 800. Let us be your partner in navigating these regulations and ensuring the safety of your staff and the integrity of your compounding processes.
Federal Agency Response Writing
When it comes to crafting formal response letters for regulatory bodies such as CMS, FDA, and other governing entities, precision and clarity are paramount. At ACW Canterlilly, our approach to writing these crucial documents involves a meticulous analysis of the rule changes or regulatory needs. We ensure that our response letters are well-structured, articulately written, and adhere to the specific guidelines and protocols set by the respective regulatory bodies. Our team focuses on conveying information with utmost professionalism, addressing the key points with accuracy and thoroughness, and providing comprehensive, well-supported arguments to support your position. Through our expertise in formal communication and regulatory compliance, we aim to deliver response letters that express your concerns or support for the subject in question, ensuring your companies voice will be heard by the federal agency on record.
ASHP Residency Consulting
At ACW Canterlilly, we understand the critical importance of ASHP residency programs and their impact on the development of competent pharmacy practitioners. Our team is dedicated to providing comprehensive consultation services tailored to your residency program’s unique needs. By offering an in-depth overview and analysis of your program and guidance documents, we aim to ensure the best possible recruitment strategies and program health. Our goal is to collaborate with you to identify areas for improvement, enhance program attractiveness to potential candidates, and ultimately contribute to the continued success and excellence of your ASHP residency program.