October 28, 2019 PAP-Q2-19-NI-006
A: Alcami aims to be “Connected at Every Level,” and our compliance and quality team members work every day to help us deliver that vision. Like all cGMP companies in the CDMO industry, we host many external and internal audits every year. Our risk-based approach promotes the internal review of activities across all systems, processes and facilities, while concurrently managing a high volume of external audits, which can range from paper assessments to full-scale mock pre-approval inspections. Alcami’s corporate regulatory and compliance team works in concert with site-based quality, compliance and leadership teams to support these audits and maintain a constant state of inspection readiness. Operational resource talent pools are leveraged across the Alcami network to tackle opportunities and potential concerns with a holistic approach.
A: RxGen is a preclinical contract research organization with global reach that offers specialized nonhuman primate models in ophthalmic, CNS and other prevalent disease conditions, with broad experience in small molecule, biologics and gene therapy candidate evaluation. RxGen partners to achieve the development objectives of sponsors in North America, Europe and Asia and complies with international animal research, regulatory and shipping guidelines, and all of those that apply within respective regions.
RxGen’s commitment to efficiently conducting resource-intensive research with the objective of improving the lives of patients is inherently a heavily social activity, built on positive relationships maintained at a local level within immediate communication and execution time frames. This includes the physical communities in which RxGen directly works and our emulating the qualities of local-level connectivity in our engagement with clients at distant sites, allowing RxGen to act as an extension of their labs. Our mission is to drive substantial gains in R&D productivity in serving the diverse needs of the biomedical research community globally. Critical to that capability is bringing immediate, firsthand know-how to demands that are specific to a given project and location — an expertise we have achieved through working long and effectively within local and global compliance standards and managing the logistical dependencies associated with multi-site science.
A: Isofol is currently advancing lead developmental candidate arfolitixorin in a global phase III clinical study in patients with metastatic colorectal cancer treated in the first line. With trial sites in the United States, Canada and Europe, we have to be keenly aware of maintaining global compliance throughout the process of designing and executing the trial. We have worked closely with regulatory agencies, as well as top oncology experts from each of these regions, to ensure that we have accounted for as many potential concerns as possible, including regulatory differences and variances in existing standard of care, to make sure that this process is as smooth as possible. We also have regular dialogue with individual trial sites in local regions to ensure that all their trial planning, enrollment and execution needs are met.
A: Catalent provides customized regulatory services for customers utilizing our contract development and manufacturing services. Compliance is interwoven into the regulatory support we provide. Whether Catalent authors applicable sections of a customer’s dossier or supports its generation, the customer provides us the applicable sections of the dossier for review and comment prior to submission, ensuring that the regulatory documentation accurately reflects the development history, Catalent’s manufacturing process and applicable Health Authority requirements. Regulatory affairs specialists also review proposed changes to assess which products are affected and the type of regulatory reporting that will be required for the change, prior to it being implemented.
We have regulatory affairs experts in various regions to help evaluate the impact of any regulatory changes for the jurisdiction in which a product is registered. Our CDMO regulatory affairs organization stays current with regulatory requirements through the experience of supporting numerous customers. Additionally, we have a dedicated regulatory intelligence team, which shares information throughout Catalent, so we can transform the information into actionable plans to mitigate risk. It is to our advantage to be well informed so we can identify opportunities and optimize product development to deliver successful outcomes for customers and the patients we all serve.
A: As the world of pharmaceuticals rapidly advances, it is more important than ever to manage both local services and global compliance. We are developing a corrective eye drop for presbyopia, also known as age-related farsightedness, which affects more than 1.8 billion people globally. Our goal is to bring a convenient and on-demand solution to these people in our local community and other regions of the world.
We have designed a strategic path forward to navigate the local and global regulatory and compliance landscape. More than 115 million people in the United States are affected by presbyopia, and that number will increase to over 130 million in the next 10 years. We want to bring a pharmaceutical solution to these people, and that’s why it’s incredibly important for us to understand the U.S. market and regulatory path. After successfully completing phase IIa studies locally in Israel, we started testing our product candidate in a phase IIb clinical study across several states in the United States.
A: As a global life science business with a complex supply chain, 59 manufacturing sites and operations in 66 countries, MilliporeSigma is structured to meet local regulations efficiently and compliantly. Adding to this complexity is a broad and deep portfolio of more than 300,000 products, which naturally implies a high number of regulations with which to comply in the various regions of the world.
MilliporeSigma’s Quality & Regulatory Management organization enables the business to commercialize or market our products globally in an increasingly stricter and ever-changing regulatory environment. The key here is to be in close contact with local authorities and to have a deep understanding and knowledge of local regulations.
How do we do this? We have a wide regulatory and trade compliance network in more than 40 countries where we need to understand local regulatory requirements and then optimize processes according to these requirements. Our regulatory colleagues are based in the respective countries, speaking the local language, are experienced with local compliance/regulatory requirements and foster collaboration with local authorities.
All around the world, we have harmonized regulatory processes that are scalable and can be customized according to the local requirements. One example is our safety data sheets, which we use to communicate product hazards and appropriate measures to manage risks during transport, storage and handling. We offer more than 25 million safety data sheets in various language combinations for following local regulations.
We are setting industry standards through subject matter expertise and fostering collaborative and fruitful dialogue with local authorities, ensuring that we implement new regulatory requirements early for compliance.
A: Every company with a large, global footprint is facing increasing complexity in local rules and regulations. That’s why it is important for our legal and compliance teams, including our lawyers, medical affairs, pharmacovigilance, regulatory, quality and other compliance professionals, to build relationships based on trust with the commercial and manufacturing teams. These close collaborations help to spot potential risks early on and speed changes in laws or business practices to the experts who can help guide decisions to mitigate big concerns.
A: At Lonza, we take compliance very seriously, as we consider it as a key factor for sustainable success. We promote a culture of full transparency and continuous improvement. Compliance is monitored and acted on through various means and across the different levels of the organization. This includes elements such as three-tier Quality Councils (site, business segment, senior management), well-established escalation paths, and tailored Quality/Compliance-related key performance indicators, as well as local and corporate audits. Globally coordinated Quality Alerts serve to share learnings across the network, and the global follow-up of regulatory inspections supports us in preventing (re-)occurrences. We stay current with the ever-changing regulatory landscape by means of global regulatory intelligence, which serves as input for adapting our quality management system (global, local) accordingly. The Global Technical Functions and Global GMP Compliance directly support sites based on individual needs (e.g., inspection readiness support).
A: At Check-Cap, we have leveraged the strong experience of our team and local medical resources in Israel for the development and optimization of our product, the C-Scan system. We initially tested the technology in the local population through clinical trials in Israel and advanced a clear path toward commercialization of the C-Scan system in international markets.
With a global vision in mind and the goal of reducing the global incidence of colorectal cancer, our experienced team always carefully assures compliance to both local and international regulatory standards and has initiated multiple discussions with local and global regulatory agencies, including the European Union, the Israeli Ministry of Health, and the U.S. FDA. Following approval of the C-Scan system in Israel and the CE Mark in Europe, our team focused efforts for the clinical trials in the United States while continuing to harness local resources for the acquisition of additional data to guide further optimization of the C-Scan system. Additionally, our company has strategically established a collaboration with a global leader in medical technology manufacturing, GE Healthcare, to assure the capability to scale up production and distribution of the C-Scan system, while assuring adherence to regulatory and safety standards in various markets worldwide.
A: CRB actively collaborates with global professional organizations, such as the International Society for Pharmaceutical Engineering (ISPE) and Biophorum Operations Group (BPOG), and has been very instrumental in the development of several ISPE Baseline® Guides and six of the eight phorums of BPOG. Our subject matter experts’ passion for technical excellence, combined with their experience in the execution of international projects, allows them to have an exceptional understanding of global compliance. This knowledge is shared with our various centers of excellence through internal workshops and summits, giving us a deep bench of resources with global experience.
Our local project teams include at least one subject matter expert with experience in the specific technology to be used and knowledge of the compliance requirements of the country where the project will be executed and/or the products will be sold. Our subject matter experts also participate in various reviews dictated by our quality program to ensure that compliance requirements are incorporated into the design of the project in a timely manner.