Suppliers Guide

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
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
The American Society of Gene & Cell Therapy
The American Society of Gene & Cell Therapy is the premier professional organization for academia, bio-industry, and stakeholders dedicated to these emerging therapeutics.
Academia
Training/Education
Waukesha, WI
Andaman Medical Pte Ltd
Andaman Medical is a regulatory affairs and market access consultancy specializing in the registration, authorized representation and importation of medical devices and IVDs in Southeast Asia.
Consulting Services Singapore
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
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

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

  Concord, 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
Innovatum, Inc.
Innovatum’s ROBAR provides many powerful capabilities for UDI/MDR/IVDR/Eudamed and is delivered with consulting, Implementation, and validation assistance. As a true end-to-end regulated labeling system provider, Innovatum has been a top innovator in life sciences labeling for over 25 years. Innovatum’s fully configurable and easily validatable RIMS/PIMS /MDM labeling systems are easily expandable to meet future regulatory needs without involving the IT department. Additional modular capabilities include, 100% label inspection and eIFU management with hosting.

Consulting
Software Solutions
Validation Services
Training
Atlanta, GA
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
Navitas Life Sciences
Navitas Life Sciences is a proven regulatory affairs partner for small to large bio-pharmaceutical companies, providing cost-effective end-to-end regulatory services, with customization of services to suit unique needs. Our Regulatory Technology and Industry Regulatory Networks help navigate the regulatory landscape, ensuring proactive compliance and enhanced operational efficiency.
Consulting Services Chennai, India
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
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.

Consulting
Quality Assurance
Burlington, MA

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

PSC Biotech

PSC Biotech® consultants act as a seamless extension of your company to assist you in accomplishing the projects required in producing the highest quality products.

Consulting Services Pomona, CA

Reed Tech 

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.

Software Solutions             Horsham, PA

RegDesk

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.

Consulting
Software Solutions
Houston, TX

RQM+Premium Solutions Partner premium solutions partner
Regulatory and Quality SolutionsRQM+ is the leading MedTech service provider with the world’s largest global team of regulatory and quality experts. We provide comprehensive regulatory, quality, clinical and laboratory services, supporting market access throughout the entire product lifecycle for medical devices and diagnostics. With more former FDA, MHRA and notified body regulators than any other firm, the RQM+ team has deep expertise in all clinical specialties. RQM+ currently works for eight of the top 10 medical device manufacturers and seven of the top 10 IVD 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 an established regulatory consulting and e-publishing firm supporting our client’s activities in the US and Canada for over 14 years. Regxia can prepare, adapt, e-publish, and submit your clinical and marketing applications to the FDA and Health Canada.

Consulting Services              Vaughan, 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
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
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
Synterex, Inc.
Delivering quality regulatory documentation requires navigating and evolving landscape influenced by regulators, research committees, healthcare professionals, and – most importantly – the scientific method itself
Consulting
Clinical Research Organization
Quality Assurance
Dedham, MA
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
Trinzo – Quality and Regulatory Consulting
Trinzo is a medical device and pharmaceutical consultancy firm with decades of quality and regulatory experience across their global consultant network. Trinzo creates bespoke, sustainable solutions to solve the industry’s biggest challenges through training, consultancy, and technical resourcing. Book your free consultation today at www.trinzo.com
Consulting, Training/Education, Staffing, Audit/Inspection, Testing/Validation, Quality Assurance Co.Galway, Ireland
University of Georgia - College of Pharmacy International Biomedical Regulatory Sciences Program
The UGA Regulatory Sciences Programs are web-based, academic graduate courses designed to prepare Regulatory Sciences professionals for careers in the Medical Device, Pharmaceutical, Biologics, and Animal Health business sectors.
Training/Education Lawrenceville, GA
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