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
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.
Consulting
Clinical Research Organization
Moon Township, PA
Agilis Consulting Group, LLC

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.

Consulting
Testing/Validation
Cave Creek, AZ

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.

Consulting
Software Solutions
Notified Body
Clinical Research Organization
Testing/Validation
Quality Assurance
Audit/Inspections
Publisher
Training/Education
Ontario, Canada
BlueReg Pharma Consulting
BlueReg is an international pharma consultancy offering European strategic regulatory advice and hands-on outsourcing solutions to US life sciences companies through services from Product Development to Life cycle management, Early Access Programs and more
Consulting Services Cambridge, MA

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.

Consulting
Quality Assurance
St Leonards, 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
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
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
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
Evidera Premium Solutions Partner premium solutions partner
Evidera Evidera, a PPD business, is a leading provider of evidence-based solutions to demonstrate the real-world effectiveness, safety, and value of healthcare products. We help biopharmaceutical, biotechnology, and medical device companies generate the evidence needed to optimize the market access and commercial potential of their products. For more information, visit www.evidera.com.
Consulting Services Bethesda, MD
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
Lindsey Regulatory Affairs Consulting, LLC
Lindsey Regulatory Affairs Consulting, LLC (DBA, LRA Consulting) strives to meet the needs of the client in every way. We are committed to the success of your business and strive to help you develop and implement regulatory and quality solutions catered to your needs.

Consulting Services             
Durham, NC

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

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
MCRA
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.
Consulting
Authorized Representative
Clinical Research Organization
Certification
Testing/Validation
Quality Assurance
Audit/Inspections
Training/Education
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.
Consulting
Authorized Representative
Certification
Audit/Inspections
Training/Education
Warsaw, IN
Opus Regulatory, Inc.
Opus Regulatory is a niche firm serving biopharmaceutical companies throughout the US. We leverage a highly focused operating model designed to deliver a superior, cost effective solution for our clients' RA project needs. We combine RA functional expertise, a network of highly experienced regulatory professionals and 25 years' experience to deliver these services. Our core Regulatory pillars include Strategy, Labeling and Advertising & Promotion. Visit OpusRegulatory.com to learn more!
Contract Consulting for Pharma Cambridge, MA

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.

Consulting
Software Solutions
Authorized Representative
Communication
Quality Assurance
Audit/Inspections
Publisher
Training/Education
Fairfax, VA

PharmaVOICE
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 

LexisNexis Reed Tech serves manufacturers and distributors of medical device and drug products, and those who support them in consulting and IT roles by delivering better outcomes for the collection, transformation, submission and analysis of regulatory data. Our solutions and services support the innovation ecosystem and enable you to achieve regulatory compliance and improved product data management contributing to impactful innovations to our world.

Software Solutions             Horsham, PA

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
SciLucent, Inc.
SciLucent provides US-based regulatory, scientific, technical consulting and authoring services to companies that develop pharmaceuticals, biopharmaceuticals, medical devices, and combination products. 
Consulting Services Herdon, VA

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

Consulting
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...

Press/Media
Publishers/Editorial
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
Telos Partners, LLC
Telos Partners is a technical services and consulting firm specializing in musculoskeletal medical devices and biotechnology. We partner with companies in this space through a tailored approach to achieve their ultimate business goals in regulatory, reimbursement, and clinical research services.
Consulting
Clinical Research Organization
Quality Assurance
Warsaw, IN
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
Veristat Premium Solutions Partner premium solutions partner
VeristatVeristat regulatory experts help sponsors solve the unique and complex challenges associated with accelerating therapies into and through clinical development to regulatory approval. Whether you need to prepare your regulatory strategy, want to begin your IND/CTA, meet with a regulatory agency, or require support preparing or submitting a marketing application - our regulatory experts can help. We supported more than 45 INDs in 2020 alone and 100+ marketing applications in the last ten years.
Consulting
Notified Body
Authorized Representative
Clinical Research Organization
Communication
Audit/Inspections
Publisher
Southborough, MA
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.
Consulting
Publisher
Training/Education
Mohnton, PA