Pharmaceutical Remediation and Regulatory Affairs

JI-Solutions are Subject Matter Experts and have taken a much larger focus on Cell and Gene Therapy and the importance of utilizing cells to help treat, prevent or mend diseases. Cell therapy process can help reduce the risk of spreading diseases, can reduce the cost of manufacturing and better stability of the product. We have utilized our Subject Matter Experts to become proficient in cell and gene therapy. The importance of quality control testing, cost and consistency of cell and gene therapy and utilizing materials including logistics help make our cell and gene therapy much more proficient and effective.

JI-Solutions LLC has technical personnel that are Subject Matter Experts in quality assurance, validation systems and manufacturing operations, and CGMP guidelines. JI-Solutions has extensive past performance working on projects such as, but not limited to; Regulatory Affairs, Manufacturing Operations, Laboratory Services Support, Warehouse logistics Operations, GMP Inspections Readiness, Compliance Operations, Regulatory Engagement, Investigation Closeout, Reduce OOS and many more.  We have over 25 plus years in the commercial pharmaceutical industry itself. Therefore, we are excited to extend our services to help with any compliance or regulatory issues you may have.    
 

JI-Solutions specializes in Consent Decree remediation services for pharmaceutical companies, providing comprehensive solutions to address regulatory compliance issues. With over 30 years of FDA experience as subject matter experts, we help pharmaceutical firms navigate the complexities of consent decrees by developing and implementing robust corrective action plans. Our approach ensures that all compliance gaps are identified and addressed, enabling companies to meet stringent regulatory requirements and restore their operations to full compliance. We work closely with our clients to not only remediate existing issues but also to strengthen their quality systems, ultimately reducing the risk of future regulatory challenges and ensuring the ongoing integrity of their operations. 

 Our company excels in FDA Warning Letter remediation for pharmaceutical companies, offering targeted solutions to address and resolve compliance deficiencies. Leveraging over 30 years of FDA experience as subject matter experts, we guide companies through the remediation process, ensuring that all issues cited in the Warning Letter are thoroughly addressed. Our team works closely with clients to develop and implement corrective and preventive action plans that meet FDA expectations. We also enhance quality management systems to prevent future compliance issues, helping our clients achieve and maintain regulatory compliance while safeguarding their operational integrity and market reputation. 

Our company is a leader in inspection readiness for pharmaceutical companies, providing expert guidance to ensure full compliance with FDA regulations. With over 30 years of experience as subject matter experts, we prepare our clients for every aspect of regulatory inspections. Our services include conducting thorough mock audits, evaluating and enhancing quality systems, and offering specialized training to ensure staff are well-prepared. We focus on identifying and addressing potential gaps before inspections, ensuring our clients can confidently demonstrate their commitment to quality and regulatory compliance. Our goal is to help pharmaceutical companies maintain high standards and avoid costly delays or penalties.

 Our company specializes in providing comprehensive GxP (Good Practice) training for pharmaceutical companies, ensuring that all employees are well-versed in the critical regulations governing the industry. With over 30 years of experience as subject matter experts, we design and deliver tailored training programs that cover Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP). Our training sessions are interactive and practical, focusing on real-world applications to reinforce compliance and quality standards. By partnering with us, pharmaceutical companies can ensure that their teams are fully prepared to meet regulatory expectations, maintain product quality, and uphold the integrity of their operations.