RJR Consulting, Inc.
Maximizing Product Quality and Faster Delivery through Expert Global Talent

The health and well-being of the patients and the public are paramount for any government. Unsurprisingly, the pharma industry is under constant pressure from the concerned regulatory authorities for drugs’ safety and quality. The challenges for pharma companies have grown manifold with the onset of COVID-19, which has thrown life out of gear globally and also created cost and resource challenges for these firms. While authorities prefer to execute their compliance-related tasks remotely at a reduced scale, pharma companies have redesigned their internal priorities due to frequent lockdowns and restricted facility access. These firms are struggling to have access to a wide range of expert quality assurance (QA) services to keep pace with their product launches and growth plans.

Founded in 2002, RJR Consulting, Inc. has risen as an expert QA consulting firm for the global life sciences industry. The company has aced the art and science of building quality management systems and frameworks to ensure the safety and reliability of products that include medical devices, Prescription / OTC drugs, and combination products. In over 95 countries, RJR provides expertise in QP support activities such as batch release, supplier audits, building quality management systems from the ground up, quality manuals, SOPs, and quality agreements. It also offers solutions in the areas of API and finished product CMO identification, QP oversight, and storage, handling, and distribution compliance.

The company’s clients, including startups and large enterprises, approach the firm with a wide range of requests depending on where they are in their journey toward product development.

RJR has maintained a team of expert and experienced professionals that keeps clients’ projects moving forward so that they are completed in time regardless of the challenges. Through remote and onsite services, the team supplements clients’ existing QA resources. It has the ability to oversee quality and compliance throughout the clients’ supply chain, as well. “To ensure a smooth compliance verification, RJR conducts Mock GCP and GMP Audits, months before health authorities perform the actual audit,” says Robert Russell, President and CEO of the company.

As speed-to-market is essential for pharma companies to maintain leadership, RJR is overcoming travel blockades through its in-country representatives who assist clients in their endeavors. The company’s affiliates are all regional experts who maintain consistent communication with the health authorities and other stakeholders in a project. “Our local experts have a solid track record of receiving answers quicker from a health authority than a remote inquiry,” says Russell.

In a case study, a large pharmaceutical company was able to include device manufacturing services by achieving all the necessary certifications through RJR. The client had just acquired the medical device business, and it required GMP certification to start the new operations. Moreover, their current quality management systems had to be tweaked to accommodate medical devices. In just six months, the client was able to update their systems and pass regulatory scrutiny that enabled them to acquire the needed CE Marks and ISO-13485:2016 GMP Compliance Certification.

Riding on the back of such success stories, RJR has expanded its QP services in Europe. The company aims to assist clients in markets that require advanced devices for their patient populations. As COVID-19 continues to hinder the global supply chain, RJR strides ahead with the promise of strong collaboration and resource availability to keep the clients’ projects ticking along seamlessly.