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 contact RAPS at advertising@raps.org

Company Business Type Location
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, Texas
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

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
Canada

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

Consulting Services
Hospital/Medical Practice
Legal
Alexandria, Virginia

Brandwood Biomedical
Brandwood Biomedical is a Quality, Regulatory and Reimbursement consultancy headquartered in Sydney with an international office network and a solid track record of excellence of over 20 years.

Consulting
Quality Assurance
Sydney, Australia
BSI Group America, Inc.
BSI Healthcare's mission is to ensure patient safety while supporting timely access to global medical device technology...
Notified Body Herdon, Virginia

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, Illinois
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, Indiana

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

  Concord , California
dicentra
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, Virginia
Fang Consulting, LTD.
At Fang, we specialize in Regulatory Affairs Consulting and Quality System Consulting for the medical device community.
Consulting Services              Minneapolis, Minnesota

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 
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              Washington DC
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, New York
MasterControl
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
Training/Education
Salt Lake City, UT
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, Indiana

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, Virginia

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

Press/Media Titusville, New Jersey

Pilgrim Quality Solutions

Pilgrim Quality Solutions is a leading global provider of enterprise quality management software and services for the Life Sciences and other highly regulated industries.

IT/Software Solutions Tampa, Florida

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, California

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) 

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

Consulting Services              Pittsburgh, Pennsylvania

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 Regulatory Management Software is a suite of cloud-based regulatory affairs software solutions offering medical device registration tracking, management and collaboration of general safety and performance requirements, standards management and tracking, and more. Medical device manufacturers now have the ability to manage the global regulatory landscape and understand the relationships between their products, countries, laws, regulations, guidelines, standards, accounts, contacts, and regulatory bodies.

Software Solutions Pittsburgh, PA

RQSolutions

RQSolutions is a Regulatory and Health Economics consulting company, based in Sydney/Australia.

Consulting Services              Chatswood, Australia

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

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

Consulting
Software Solutions
Quality Assurance
Cambridge, Massachusetts

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
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