ExL’s 8th Proactive GCP Compliance Conference offers an in-depth education on building quality risk management approaches into clinical operations to optimize research, maintain GCP compliance and contain costs. The forum attracts mostly senior-level clinical quality and operations professionals from leading pharma, biotech and device companies of varying sizes, making it an ideal event for networking and forming new business relationships.
ClinAudits is a truly independent organization providing auditing and compliance consulting services domestically and throughout the world. Continuing for more than 20 years, clients receive customized services requiring expertise and direct experience with GCP, GTP, GMP, GLP, REMs, tobacco and animal health. All activities are coordinated centrally from our offices in northern New Jersey. Regionally based, senior-level auditors conduct on-site or remote audits and other compliance services relating to preclinical research through Phase 4 development programs, and onto commercialization of products. Be it a need to address a single, immediate QA event or to serve the complete QA function, ClinAudits’ approach is to clarify the specific need and then develop and implement an effective plan, all while delivering exceptional quality, service and value.
DArcy Consulting is a pharmaceutical compliance consulting company formed to address a very specific need in the market – the need for practical, implementable solutions to quality and compliance issues. Simply put, we help you become more compliant. Whether in clinical or any other part of R&D, we believe that a compliance culture is for everyone. It is not a tax on the business but rather a critical business enabler that drives enhanced business performance.
Halloran Consulting Group
Halloran Consulting Group makes life science companies better at what they do. We give you the direction and expertise needed to transform your company into a more efficient organization where quality is part of the culture, not an afterthought. We stick by your side when things get tough by helping to identify and fix problems within your organization. We’ve been there. We can find a solution.
MasterControl quality management software and services enable research and manufacturing companies in the life sciences to increase compliance while reducing time to market. MasterControl offers solutions for the entire enterprise, including clinical, regulatory and quality management with document control (e.g. GxP); document management (e.g. eTMF); study management; monitoring; audit management; regulatory submission management; training management; supplier management; deviation management; CAPA; and more.
SKILLPAD helps clients in pharmaceuticals, biotechnology and other regulated industries reduce costs, increase profitability and improve efficiencies through e-learning. We produce custom performance improvement and critical task modules, and have an extensive collection of off-the-shelf lessons in our e-learning library. SKILLPAD has just released Premium Lesson Suites on Clinical Inspection Readiness and Serialization.
Our subject matter experts use their regulatory (GxP) compliance backgrounds, project management expertise and approach in risk-based quality processes to lead our clients to a trouble-free project realization in less time for quality, inspection readiness and knowledge transfer projects.
Skillpad offers project managers and subject matter experts in regulatory services to reduce costs, decrease risks and improve efficiencies while maintaining quality.
Zigzag Associates Ltd is a Global Quality Assurance (‘QA’) consultancy company based in the UK, who can provide a team of highly experienced QA professionals to support you. Whether you need ad hoc support, a more regular commitment through outsourcing, or an experienced team to partner with on audit programs, we can offer you a flexible, pragmatic and responsive global service tailored to suit your requirements. We specialize in audits, inspection readiness, Quality Management Systems and training.