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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
Resources, news and special offers to support you and your professional development during this difficult time.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Convergence 2020 has come and gone, but you can still access recorded sessions, which are available to attendees until 31 December 2020.
Replay the moments of Euro Convergence 2020. Recorded sessions are available to attendees until 31 January 2020.
RAPS' “how to” guide to developing a comprehensive global regulatory strategy for all types of medical devices. Updated September 2020.
From self-assessments to help you identify your strengths and areas to focus on to reference books and online courses that will help you fill in the gaps in your regulatory knowledge, RAPS has the resources to help you prepare for the RAC exam.
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RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.
The suppliers guide is a resource of services and solutions for regulatory affairs professionals and their companies. Listings do not imply a product or service endorsement by RAPS.
Suppliers interested in adding their services to the guide can submit a request online.
All Language Alliance, Inc. provides multilingual medical, pharmaceutical, legal document translation and interpreting services from and into Simplified Chinese, Korean, French, German, Traditional Chinese, Italian, Japanese, Korean, Brazilian Portuguese, Spanish, European Portuguese, Hebrew, Arabic, Norwegian, Turkish, Greek, Swedish, Dutch, Finnish, English, and other foreign languages.
Our medical and pharmaceutical translators and interpreters provide confidential translations of multilingual documents for regulatory submissions to the FDA and other regulatory agencies worldwide; translations of Clinical Trial Protocol (CTP), clinical trial data and summaries; Summaries of product characteristics (SPCs); Instructions for Use (IFU); medical records; physician reports; manuals for medical devices; articles for medical journals; life sciences patents, and other documents. For additional details see: https://www.languagealliance.com/medical-translation/
AxSource Consulting Inc. AxSource Consulting Inc. services in Clinical Affairs, Regulatory Strategy & Submissions to FDA, EMA, MHRA, Health Canada and TGA, eCTD Publishing, NHPs, Nutraceuticals, Cosmetics, Medical Cannabis, Compliance services (MDSAP, ISO 13485, GLP, GCP, GMP, GDP & GPP), Training, Pre-Inspection readiness, QMS and Quality Audits, Pharmacovigilance, Process & Software Validation and Litigation Support. Microsoft ERP Quality & Compliance software solutions developed - QCS™ for pharmaceuticals, devices & OCS™ for Medical Cannabis.
Bennett and Company Bennett and Company provides a variety of regulatory and quality system consulting services to companies...
Brandwood CKC Brandwood CKC is the premier regulatory, quality systems and reimbursement consultancy in Australia serving local and international healthscience innovators for more than 20 years.
CJP Consulting, Inc. CJP Consulting, Inc. develops and updates corporate quality systems, prepares and submits class II medical device 510(k) applications, prepares companies for FDA inspections and Joint Commission accreditation surveys, and provides ongoing regulatory advice and support. CJP Consulting is based in Chicago, IL and has clients across the U.S. Services are customized to fit the needs of the client to ensure complete satisfaction every time.
DEKRA Certification DEKRA Certification is a world-class Notified Body, with offices in the US, The Netherlands, Germany,...
EAS Consulting Group EAS Consulting Group, LLC (EAS) specializes in Food and Drug Administration (FDA) regulatory matters. Our ...
G&L Scientific Founded on the principle of great people backed by great customer service, G&L Scientific is a market leading, multinational, scientific consultancy with over 20 years of deep domain experience in the fields of Regulatory Affairs and Quality Assurance.
GlobalVision GlobalVision's quality control software platform helps businesses accelerate quality inspections of packaging, documents, artwork, inserts, cartons, labels, and more.
HartmannWillner LLC Since 2009 we have advanced the development of over 130 products. We are a boutique FDA biologics consulting group specializing in biologics, biosimilars, biotechnology, and biologic device combination products.
PharmaLex US Corporation PharmaLex provides Regulatory Affairs, Quality & Compliance, and Medical Device Services. We utilize the breadth of our experienced multidisciplinary team, as well as our extensive global network, to help clients navigate the regulatory landscape.
PharmaVOICE PharmaVOICE magazine, reaching more than 25,000 BPA-qualified life-sciences executives, is the forum that allows business...
Promedica International
Promedica International is a privately held, full-service, ISO-certified CRO providing clinical trial services for the medical device, biotechnology and pharmaceutical industries.
Reed Tech
Reed Tech offers product and service solutions to help Life Sciences professionals gain control over their own and their industry's data. Our offerings smooth the collection, transformation, submission and analysis of regulatory data for manufacturers and distributors of medical device and drug products, and for those who support them in consulting and IT roles.
RegIQ Solutions
RegIQ Solutions is the developer of Magellan, a sophisticated regulatory guidance SaaS platform for medical devices and diagnostics. It features comprehensive, device-specific intelligence in 60 countries and 10 global regions, on-board project management to keep regulatory team members aligned, on task and on budget, a document manager for document review and tracking and a license manager with pro-active alerts to keep licenses active and current.
Regulatory and Quality Solutions (R&Q) Premium Solutions Partner Regulatory and Quality Solutions (R&Q) provides integrated quality and regulatory consulting solutions to medical device companies.
Regulis Consulting LTD Regulis is a global regulatory affairs and pharmacovigilance consultancy, specialising in delivering client growth and protecting client assets. From the strategic to operational, we get you through the maze of regulation for medicines, biotechnology products, medical devices and borderline substances. We work with companies to speed their products to market and protect their patients and the value of their products. With our knowledge and expertise, Regulis increases revenue, decreases risk and reduces cost for clients.
Regxia Inc Regxia is a unique scientific and regulatory consulting firm servicing the pharmaceutical and biotech industries....
Rimsys Regulatory Management Software
Rimsys is a world-leading Regulatory Information Management (RIM) software for medical technology companies that digitizes, automates, and creates regulatory order. The only holistic RIM software for medical devices, in-vitro diagnostics, and medical device software, Rimsys makes it easy to navigate the pillars of regulatory affairs, including product registration, standards management, essential principles/GSPR, and regulatory intelligence. Rimsys is a holistic platform built by and for regulatory affairs professionals to efficiently ensure that products adhere to changing global regulations.
RWS Life Sciences
RWS Life Sciences is a leading global provider of language solutions exclusively for life sciences. We have built a reputation of excellence for solving the most complex and demanding multilingual challenges in the areas of clinical trial management; regulatory affairs; medical devices; linguistic validation; E-learning and training; and marketing communications.
Schlafender Hase Schlafender Hase® provides a text and graphic proofreading software called TVT (Text Verification Tool®)....
Securing Industry, Ltd. SecuringPharma.com is a free-to-access information service that covers the issues surrounding supply chain and brand...