An FDA or EMA meeting is the wrong time for an original thought.
We get you ready for your toughest stakeholder conversations and payer negotiations.
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.
High quality, trusted products to get and stay healthy.
Bringing accurate, timely information to better manage your health.
Leading in less-invasive technologies and connected care solutions that fit easily into your life.
Science-based products for every stage of life.
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.
AssurX Change Management provides a robust solution than that will help your organization facilitate, control and sustain any type of change with compliance enablement built in.
The AssurX EU MDR MIR electronic reporting solution automates Manufacturer Incident Reporting, enabling timely post-market reporting of applicable medical device vigilance incidents.
AssurX eMDR automates the generation and submission of electronic medical device reporting (eMDR) for MedWatch 3500A reports direct to the FDA Gateway.
The robust AssurX Platform is rich in features and highly configurable workflows for quality and regulatory compliance that make critical quality management and regulatory compliance tasks simple, transparent, and automated.
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.
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.
China Med Device provides turnkey solutions for all clinical pathways in medical device/IVD/CDx/combination products. Key clinical pathways are: Clinical evaluation report (CER), and clinical trial, overseas clinical data acceptance, real word data (RWD).
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.
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.
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.
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.
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.
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.
The benchmark for regulatory information management, Samarind RMS suite is a fully integrated software solution that has been purpose built to mirror the processes associated with acquiring and maintaining product licenses.
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.
Understanding emerging regulatory requirements in Cell & Gene Therapy
The IQVIA Regulatory Intelligence solution and reporting service that ensures you have an abundance of FDA advisory committee meeting details.
Your window to regulatory requirements across the globe
Answering some of the key questions in the area of Clinical Trial for Medical Devices
Staying ahead of emerging regulations in software as a medical device
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.
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!
NAMSA Medical Writing Services
NAMSA Regulatory and Quality Consulting Services
NAMSA Reimbursement Consulting Services
At the intersection of Law, Business, and Science
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.
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.
Membership gives you access to countless resources and a vast network of professionals all dedicated to the field of regulatory
Members' one-stop location to access RAPS member benefits.
RAPS continues to monitor the on-going Coronavirus pandemic and has resources to help you stay informed on this rapidly evolving situation.
RAPS Regulatory Exchange, aka RegEx, is where members gather online to learn, grow, and engage with other regulatory professionals who have similar interests and goals. Through its open forum, members network, ask questions, and share resources.
RAPS Regulatory Focus is the only source of timely, quality regulatory news, information and analysis that is fully dedicated to covering regulatory issues associated with healthcare products and the regulatory profession.
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.
A resource to track updates in therapeutics for COVID-19.
A resource to track vaccine candidates for SARS-CoV2, the novel coronavirus.
A series of articles written by and for regulatory professionals.
Global regulatory news, features, intelligence and more, delivered to your inbox each weekday.
Your daily regulatory news and intelligence briefing.
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.
High-level guide through the due diligence process from a regulatory affairs perspective.
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.
RegDocs365 - Regulatory Submissions and Collaboration Solutions for Life Sciences Companies and CROs
R&Q provides support with transitioning to EU MDR and IVDR compliance. Why R&Q?
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.
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
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
Built by and for regulatory affairs professionals in medtech
Easy to start and simple to scale as your company grows
Used and trusted by the world’s leading medtech companies
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.
TVT Artwork automatically locates deviations in full-page artwork files that can be easily overlooked during a visual comparison.
With TVT Spelling users can quickly and accurately check spelling in all major EU languages.
With TVT®, prevent misprints and recalls, reduce the time you spend proofreading and ensure only approved content is printed or published.
TrackWise Digital Cloud QMS allows you to manage core quality and compliance processes in a streamlined manner. Leverage machine learning and natural language processing to auto-categorize the intake of complaints and quality events.
Helping you make healthcare better is what we do.
You specialize in your patients. We specialize in you. We are committed to delivering innovative technology and specialized services targeting spine, cranial and neurovascular applications with a focus on your needs as a caregiver and to the bottom line.
We know Orthopaedics. It’s in our bones. We focus on anticipating your needs for innovative products and services that help us create the future together with you … where your patients get back to doing what they love.
Your submission success - accelerated and assured.
Customized submission support that accelerates and anticipates
Synchrogenix regulatory writers offer deep technical and therapeutic expertise across all submission document types to create and deliver successful submission documents on time, every time.
Communicate with confidence.
Enhance engagement. Meet requirements. Maintain compliance.
Our IT Services focus on building a strong user experience with collaboration services, Office 365, managed mobility services, desktop virtualization, IT training, and rapid response support for collaboration tools.
We offer several key services in the life sciences space covering regulatory, clinical science, publishing, and more!
Learn more about TUV USA's ISO 13485:2016 and MDSAP medical device certification services.
TUV USA offers a variety of certifications aside of medical device certifications.
Consulting on Chinese regulatory strategy, post market monitoring and reporting. Trademark registration, market research, supplier management. We do our best to support our clients.
Registering your products with China National Medical Product Administration (NMPA) based on the product classification and relevant requirements. We manage the entire process from document drafting, submission to final approval.
A collection of regulations that NMPA published in 2014, which are still active.
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