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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

Company Business Type Location
All Language Alliance, Inc.

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/

Translation Services Highlands Ranch, CO
Asia Actual LLC
Asia Actual specializes in the registration and compliance of medical and diagnostic devices in Asian markets. Experienced, local regulatory experts work closely with clients to address even the most challenging novel and high-risk device registrations. We provide transparent and efficient support in otherwise complex markets.
Consulting Austin, TX
A Wright Path, Inc
A Wright Path’s experienced team will execute and navigate the FDA and global regulatory requirements and submissions so you can launch your product into the marketplace confidently.
Clinical Research Organization
Moon Township, PA

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.

Software Solutions
Notified Body
Clinical Research Organization
Quality Assurance
Ontario, Canada

Bennett and Company
Bennett and Company provides a variety of regulatory and quality system consulting services to companies...

Consulting Services
Hospital/Medical Practice
Alexandria, VA

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.

Quality Assurance
Sydney, Australia
Cardinal Health Regulatory Sciences
Cardinal Health Regulatory Sciences is your partner for expertly navigating the complex and evolving regulatory landscape. Our accuracy eliminates costly rework, our efficiencies free up critical time, and our experience allows us to tailor each step of the process to your unique needs. Together, we remove obstacles and strengthen your success, from drug discovery to commercialization.
Consulting Services Dublin, OH
Celegence provides services and technology to support the Pharmaceutical and Medical Device industry with regulatory affairs operations and strategy. Our results-oriented service blends depth of expertise, flexible delivery frameworks and a collaborative approach. We leverage an onshore/offshore model to cover all phases of the product lifecycle from regulatory strategy, authoring, and registration management including interaction with health agencies/notified bodies. We have a strong focus on EU MDR compliance including CER & other post-market report writing.
Consulting Services Chicago, IL
Certara Premium Solutions Partner premium solutions partner
Certara Certara optimizes R&D productivity, commercial value and patient outcomes through its unique portfolio of model-informed drug development, regulatory science, and market access solutions. In fact, 90+% of all novel drugs approved by the US FDA in the past six years were supported by Certara software or services. Its clients include 1,600 global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 60 countries.
Consulting Services Princeton, NJ

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.

Consulting Services              Chicago, IL
Covance Premium Solutions Partner premium solutions partner
Connected insights, life cycle integration, passionate experience and resource ingenuity - Meet Covance Medical Device and Diagnostic Solutions. Say Hello to a new device development model that interlaces efforts across every stage of your product’s development – preclinical, clinical and post-market. All driven with an insightful strategy that addresses regulatory, quality, health economics, reimbursement, testing and trials, education, patient safety and more.
Consulting Services Indianapolis, IN
CSOFT Health Sciences Premium Solutions Partner premium solutions partner
CSOFT Health Sciences provides end-to-end medical translation services for all phases of the product lifecycle, from pre-clinical to post-launch.
Consulting Services              Boston, MA
Commissioning Agents, Inc.
CAI knows quality and risk control systems (FMEA, HACCP) that form the basis of current GMP in drug and food manufacturing.
Consulting Services              Indianapolis, IN

DEKRA Certification
DEKRA Certification is a world-class Notified Body, with offices in the US, The Netherlands, Germany,...

  Concord, CA
dicentra is a professional consulting firm that specializes in addressing all matters related to safety, quality and compliance for all product categories in the life sciences and food industries...
Consulting Services              Ontario, Canada

EAS Consulting Group
EAS Consulting Group, LLC (EAS) specializes in Food and Drug Administration (FDA) regulatory matters. Our ...

Consulting Services              Alexandria, VA
Elexes Medical Consulting
Elexes helps with Product development, Clinical, Regulatory, and Quality documentation. We offer Pre and Post-market stages of medical devices for US (FDA), India (CDSCO), Europe (CE Mark, ISO13485), Australian, Canadian, and Saudi Arabian markets.
Consulting Services Dublin, CA
Fang Consulting, LTD.
Fang Consulting has provided regulatory affairs and quality consulting to the medical device industry since 1999. We offer a variety of approaches to meet our clients’ unique needs. We have proven experience from premarket submissions to postmarket compliance for both FDA and EU MDR regulatory requirements. Our team of experts ensure that our clients obtain the regulatory approvals for new products as well as maintain their existing products on the global market.
Consulting Services              Roseville, MN

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.

Consulting Services Warren, NJ

GlobalVision's quality control software platform helps businesses accelerate quality inspections of packaging, documents, artwork, inserts, cartons, labels, and more.

Consulting Services Canada
Hogan Lovells
Hogan Lovells operates on a global scale, coordinating among lawyers in offices in all of the world’s major medical markets to sequence and streamline regulatory approvals.
Consulting Services              Washington, DC

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.

Consulting Services Naples, FL
Lachman Consultant Services Inc.
Lachman Consultant Services Inc. (LCS), founded in 1978, is a worldwide leading provider of expert technical, compliance and regulatory services in all FDA-related areas.
Consulting Services Westbury, NY
MasterControl’s integrated solutions accelerate ROI and increase efficiencies by automating and securely managing critical business processes throughout the entire product lifecycle. More than 1,000 companies worldwide, ranging in size from five employees to tens of thousands, rely on MasterControl cloud solutions to automate processes for new product development, clinical, regulatory, quality management, supplier management, manufacturing and post-market surveillance. MasterControl solutions are well-known for being scalable, easy to implement, easy to validate and easy to use.
Software Solutions
Quality Assurance
Salt Lake City, UT
MCRA offers consulting services in US and International Regulatory, a full-service CRO, Reimbursement, Quality Assurance, and Healthcare Compliance
Consulting Services Washington, DC
NAMSA Premium Solutions Partner premium solutions partner
NAMSANAMSA is the only 100% medical device-focused, full continuum Contract Research Organization (CRO). Driven by our global regulatory expertise and in-depth therapeutic knowledge, NAMSA is dedicated to accelerating medical device product development, offering only the most proven solutions to move clients’ products through the development lifecycle efficiently and cost-effectively. From medical device testing; regulatory, reimbursement and quality consulting; and clinical research services, we are the industry’s premier, trusted partner for successful development and commercialization outcomes.
Authorized Representative
Clinical Research Organization
Quality Assurance
Toledo, OH
Network Partners
Network Partners provides expert regulatory and quality resources when you need them. Let our subject matter experts and ex-FDA personnel help you achieve your corporate objectives in a compliant and efficient manner.
Authorized Representative
Warsaw, IN

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.

Software Solutions
Authorized Representative
Quality Assurance
Fairfax, VA

PharmaVOICE magazine, reaching more than 25,000 BPA-qualified life-sciences executives, is the forum that allows business...

Press/Media Titusville, NJ

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.

Consulting Services              Costa Mesa, CA

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.

Software Solutions             Horsham, PA

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. 

Software Solutions              Jacksonville, FL

Regulatory and Quality Solutions (R&Q) Premium Solutions Partner premium solutions partner
Regulatory and Quality SolutionsRegulatory and Quality Solutions (R&Q) provides integrated quality and regulatory consulting solutions to medical device companies.

Consulting Services              Pittsburgh, PA

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.

Consulting Services              United Kingdom

Regxia Inc
Regxia is a unique scientific and regulatory consulting firm servicing the pharmaceutical and biotech industries....

Consulting Services              Toronto, Ontario

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.

Software Solutions Pittsburgh, PA

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.

Translation Services East Hartford, CT
SAI Global Premium Solutions Partner premium solutions partner
SAI Global premium solutions partnerSAI Global is a trusted and established standards partner providing clients with expertise and vital knowledge needed to ensure compliance and achieve strong business performance.
Software Solutions
Quality Assurance
Milton Keynes, England

Schlafender Hase
Schlafender Hase® provides a text and graphic proofreading software called TVT (Text Verification Tool®)....

Software Solutions
Quality Assurance
Cambridge, MA

Securing Industry, Ltd.
SecuringPharma.com is a free-to-access information service that covers the issues surrounding supply chain and brand...

Bromsgrove, UK
Strategic Regulatory Solutions, Inc.
Strategic Regulatory Solutions, Inc. (SRS) provides Quality Assurance, Regulatory Compliance and Regulatory Affairs consulting services to the medical device design and manufacturing companies of all sizes.
Consulting Services Mission Viejo, CA
Temple University - Regulatory Affairs and Quality Assurance Graduate Program
Temple University's graduate program in Regulatory Affairs and Quality Assurance is the oldest and most comprehensive academic curriculum of its kind.
Certification Fort Washington, PA
WAYS Pharmaceutical Services
WAYS Pharmaceutical Services specializes in delivering excellence in regulatory and submission execution, enabling Life Sciences Companies to focus on drug development and strategy. Our primary areas of focus are regulatory eCTD submission publishing and training, as well as regulatory advisory services.
Mohnton, PA