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Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
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/
Agilis Consulting Group is your trusted human factors partner for the global medical market. Our services include human factors strategy consulting, early user research to late stage and post-market human factors studies.
We help new and established companies achieve successful human factors submissions while navigating the complex global regulatory landscape, resulting in safe and effective medical products being brought to market. Agilis’ proven human factors strategies, process and expertise drive regulatory success and speed to market – the first time.
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.
DEKRA Certification is a world-class Notified Body, with offices in the US, The Netherlands, Germany,...
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.
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.
PharmaLex is a leading provider of specialized services for the pharmaceutical, biotech and medtech industries. We guide you from early strategic planning activities and non-clinical requirements through clinical development, regulatory submission processes and post-approval / maintenance post-launch activities.
PharmaVOICE magazine, reaching more than 25,000 BPA-qualified life-sciences executives, is the forum that allows business...
Promedica International is a privately held, full-service, ISO-certified CRO providing clinical trial services for the medical device, biotechnology and pharmaceutical industries.
LexisNexis Reed Tech is a leading provider of regulatory compliance solutions and services to 300+ medical device customers, 1000+ SPL customers, and annually responsible for 33% of all electronic submissions to the FDA GUDID including 55,000+ SPL submissions. Specializing in Unique Device Identification (UDI) requirements for global health authorities, they serve about half of the top thirty medical device manufacturers and seven of the top ten providers of pharmaceutical products worldwide.
RegDesk is the one-stop solution to your company’s regulatory challenges. Our AI-powered platform automates the entire medical device product lifecycle, allowing users to create approval-ready applications in hours rather than months, track registration progress, and receive important resubmission alerts and change notification data, all from one easy-to-use dashboard. We multiply the efforts of your regulatory affairs team so you can reach new markets ahead of the competition.
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 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.
Securing Industry, Ltd.
SecuringPharma.com is a free-to-access information service that covers the issues surrounding supply chain and brand...
Schlafender Hase provides a text and graphic proofreading software called TVT (Text Verification Tool®). TVT saves time, prevents errors, costly misprints and recalls. TVT was built for Life Sciences as it ensures that only approved content is printed or published. Schlafender Hase is proud to be known for product quality, service excellence and customer success.