KPMG’s goal is to help our clients improve efficiency within their Regulatory Affairs function by implementing process and technology changes. These transformational changes help Life Sciences companies bring products to market more quickly, while reducing compliance risk and enabling a sustainable approach to regulatory maintenance activities. We provide a wide range of services including current-state assessment, future-state design, technology implementation support, data collection & harmonization, program management, and change management. We have a proven record of success and have served many of the top Pharma and Med Device companies.
Are you ready for EU MDR? KPMG offers extensive experience supporting EU MDR readiness programs. We provide a range of services including: EU MDR Readiness Assessment QMS Assessment Risk Management Technical file and CER remediation Post Market Surveillance and EUDAMED strategy Labeling assessments Notified Body audit support The above services ensure your organization is equipped for the upcoming MDR / IVDR requirements, as well as provide a roadmap for navigating the transitional provisions in place until May of 2024.
R&Q provides support with transitioning to EU MDR and IVDR compliance. Why R&Q?
The AssurX Complaint Management solution automates management of the entire complaint lifecycle, guiding users through intake, investigation, root cause analysis and regulatory reporting. Built-in configuration capabilities move complaints to closure while meeting compliance requirements and improving product safety and customer satisfaction.
China NMPA has its own specific and special requirements for product registration, renewal, and modification. China Med Device’s team has years of hands-on experience for China registration with 1000+ certificates approved. We review and prepare the registration dossier, provide on-site type testing support, communicate closely with NMPA to accelerate our clients to get their product to enter China market.
Pharma manufacturers are faced with mounting costs and liability concerns in the face of a fractured (and growing) landscape of drug take-back regulation. Inmar mitigates legislative and financial risk with a full-service drug take-back program built for efficiency.
Parexel’s virology inspection experts have created a 4-step methodology to help companies shield themselves from the risks of COVID-19 transmission. Our services are custom built around understanding viral transmission mechanisms. We evaluate your company’s environmental and physical factors, and understand your employee and business needs to develop a custom assessment and to provide a comprehensive risk mitigation framework tailored for your business. We have global expertise in public health, virology, infectious disease controls, GMP, facilities design and bioengineering.
The foundation of Parexel’s remote desktop audit capabilities is our five-point assessment process. This process utilizes a suite of virtual tools to allow for the evaluation your facilities and capabilities, performance of SMEs interviews, and assessment of evidence of the implementation and control in order to make an informed evaluation of your site’s cGMP compliance. Whether you are an application owner, global pharmaceutical manufacturer with a single site or multiple sites, CDMO, contract laboratory, start-up company or seeking vendor audits, Parexel will work with you to review your organizational needs and determine the right approach for you. We have conducted hundreds of audits and assessments globally, covering a variety of product types, sizes, histories and technical complexities.
Inmar’s RxT DSCSA cloud-based subscription platform allows users to be in full compliance with the Drug Supply Chain Security Act. This regulation was enacted in 2013 as a ten-year phase in regulation as an effort to minimize the threat of suspect and counterfeit drug products entering the US supply chain.
This ninth edition of Fundamentals of EU Regulatory Affairs focuses on the significant transformation of the healthcare product regulatory landscape in the European Union (EU), including the impact of Brexit and the European Medicines Agency’s (EMA) move from London to Amsterdam.
This book provides a “how to” guide to developing a comprehensive global regulatory strategy for all types of medical devices, including discussions on the development and implementation of global regulatory strategies for medical devices, labeling, clinical, risk management, marketing and postmarketing.
The new edition of Global Pharmaceutical and Biologics Regulatory Strategy outlines a systematic approach, spanning everything from the earliest stages of research and development to postmarketing, taking into account the challenges and realities of a global strategy to meet the requirements of multiple regulatory systems.
China Med Device (CMD) assists IVD and CDx manufacturers to comply with China regulations throughout the whole product life cycle. From preparing regulatory strategies to providing registration/renewal/modification submission and post-marketing surveillance (PMS) services, we deliver unparalleled expertise. With proactive interactions with regulatory offices as well as the clients, CMD will enable your success on China entry.
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.
Inmar manages more than 200 active recalls every day. From notification to witnessed destruction, we offer complete, end-to-end recall services for OTC and prescription pharmaceutical manufacturers to protect the integrity of their supply chain and their data.
Everything from one hand : Technical documentation, clinical affairs, verification, regulatory affairs, and QM: With us, you obtain everything from a single source. This releases immense synergy effects for your product. You are strong in development and marketing – for anything else you have us!
The Center for Regulatory Science at San Diego State University (SDSU) provides online education and training to enhance the professional excellence and career opportunities of scientists in the pharmaceutical, biotechnology and medical device industries. Programs include a fully online Master of Science Degree as well as an Advanced Certificate in Regulatory Affairs.
The R&Q EU MDR expert team has developed a PMCF survey process that is holistic and flexible around medical device manufacturers’ needs as part of an “end-to-end” PMS solution, including the critical task of managing NB expectations. R&Q’s holistic approach is based on inter-dependent processes of Risk Management, Clinical evaluation and Post Market Surveillance. In particular the approach includes identifying gaps from CER’s and residual risks (from risk management), development of a PMCF strategy taking into account considerations for products that currently bear the CE mark per MDCG 2020-6, and creating a PMCF plan per MDCG 2020-7 that is aligned with a PMCF survey. Based on a calculated sample size, the survey is deployed with subsequent data held in a compliant EDC platform with an integrated statistical package used for the data analysis and a PMCF report is created per MDCG 2020-8.
The Chinese government is enhancing efforts in post-market surveillance by investing heavily in both financial resources as well as implementing more comprehensive and stricter regulations. China Med Device QA team can help our clients to establish a compliant Quality Management System, provide incident solutions for adverse events, recalls, and overseas inspection.
If you want to be heard, have an impact, and feel challenged then R&Q is where you belong. Our consultants are employees and part of the R&Q family - no staffing agencies here! We are passionate about fostering a rewarding culture where the and means more in all that we do. Together, we are a team of highly skilled, optimistic, and passionate professionals improving lives through the work we do and the efforts in our communities. Learn more about our culture and open positions on our brand-new career webpage at www.RQTeam.com/Careers
China medical device/In-Vitro Diagnostic (IVD) regulations are ever-changing with increasing complexity. Our integrated and seasoned team can help you develop a customized RA strategy and deal with complex regulatory challenges. Our team excels in three critical areas: technical, clinical, and regulatory.
The RAC designation represents a commitment to ongoing education and professional development. After passing the RAC exam, RAC holders are required to maintain status by acquiring 36 hours of recertification credits every three years. Recertification credits are awarded for participation in educational and professional activities
Regulatory Affairs Certification (RAC), is the leading post-academic professional credential for regulatory professionals in the healthcare product sector. Regulatory Affairs Certification tests expertise in two sectors, pharmaceuticals and medical devices, and candidates may choose whether to take the RAC Drugs exam or the RAC Devices exam.
Regulatory Affairs Certification (RAC), is the leading post-academic professional credential for regulatory professionals in the healthcare product sector. The RAC covers content in pharmaceuticals and medical devices, and candidates may choose whether to take the RAC Drugs exam or the RAC Devices exam.
Throughout the clinical development process, interactions with the regulatory authorities are strongly encouraged but the response timelines are often prohibitive and clinical development teams tend to stick to the strict minimum. We’ve captured thousands of sponsor-FDA exchanges made accessible to you through a simple but smart search tool to help you better understand the agency’s expectations, prepare for scheduled meetings and optimize your clinical development strategy.
The Samarind RMS Drug Safety Solution offers one of the most efficient and practical ways to manage all business-critical pharmacovigilance activities from within a single environment. Today’s Regulatory Affairs Specialists are now accessing, processing and analyzing all of their regulatory data in one place, with complete confidence.
Designed as a reference guide, the book is broken into sections that can be quickly navigated through, giving reference to the original EU IVDR text and what requirements must be met. It does not replace the EU IVDR text, which should be used in conjunction with this guidebook.
R&Q’s mission is to help patients get the devices they need by helping device and combination product companies get their safe and effective products to market. R&Q provides the full spectrum of Regulatory and Quality Assurance support, with large team of subject matter experts including former CDRH Scientific Reviewers.
Throughout the year, we offer complementary resources in a variety of platforms that provide upcoming and on-demand education, commentary from thought leaders, Q&A features, and more. Subscribe to our blog for updates on our offerings at https://resources.rqteam.com/rq-blog-subscription
Parexel is ideally positioned to help you make a seamless transition to a virtual environment for your next Health Authority meeting. With one of the industry’s largest and most experienced teams of former regulators on staff, we know how these professionals think – because we’ve been there. We know exactly how to navigate the shifting regulatory landscape and understand the expectations of regulators in these tumultuous times. You can rely on us for this first-hand expertise and innovative thinking to chart the optimal development pathway for your novel product. With our support, you can create that “in-room” experience virtually – so vital, because getting it right is essential. Patients are waiting for your breakthrough.