Unlock the key to MedTech development with a holistic approach
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A Holistic Approach: JGS is a strategic clinical, regulatory and reimbursement consultancy for MedTech and Life Science companies. We uniquely combine programs for development, implementation and commercialization. With our capacity to execute your customized commercialization plan, we decrease your time to market and help you impact lives globally with a holistic approach.

JGS is an international multi-faceted consulting group that assists clients nationally and internationally with regulatory, reimbursement, CRO services, and clinical trials. 

We partner with our clients to develop and implement strategic solutions for new and existing medical technologies to enter the US market. 

 A HOLISTIC APPROACH:

Clinical - Regulatory - Reimbursement
                                  

REIMBURSEMENT SERVICES

-Customized reimbursement assessment
-Comprehensive competitor analysis including a clinical literature review and evaluation
-Coding assessment
-Comprehensive payer analysis (Medicare and Medicaid)
-Commercial payers
-Investor due diligence evaluations 
-Pricing and reimbursement rates
-Actionable blueprints
-Clinical protocol reviews
-Strategic reimbursement planning
-HCPCS/CPT/PLA code applications
-Marketing initiatives
-Payer advocacy
-Coverage policy review
-Reimbursement call center services
-Insurance verifications
-Claims submission assistance
-Appeals assistance
-Specialized claims submission
-Patient Assistance Programs/Compassionate Care Programs
                                          

REGULATORY SERVICES

-Regulatory assessment
-Complete, submit and manage regulatory submissions and communicate with regulatory authorities (Class I, II, III): FDA, Health Canada, EU, China, Japan, Australia, and Israel. 
-Global regulatory strategy development
-Labeling and advertising review
-Pre-IDE meeting
-Pre-market submissions: 510(k), PMA, BLA, HDE
-Compliance with 21 CFR 820 and 21 CFR 803, Canadian and EU regulations
-Quality systems, compliance and audits
-FDA U.S. Agent for foreign company representation
-Device classification and predicate devices
-Medical device reporting
-Establishment of technical files
-Due diligence assessments
-SOPs

 

CLINICAL SERVICES

-Clinical trial design
-Clinical trials
-Pre-clinical consulting
-First-in-Human and Early Feasibility Studies
-Analytic and biometrics
-Clinical operations
-Clinical strategy
-Site initiation and management
-Study monitoring
-Data file management
-Medical Affairs
-Project Management
-Quality Systems
-Safety management
-Study oversight 

 

INTERNATIONAL COMMERCIALIZATION PROGRAM 

JGS designed an International Commercialization Program (ICP) for MedTech and Life Science companies to assist them with regulatory, reimbursement and commercialization for US market entry. We de-risk your investment by cutting costs and reducing time to market by providing a turnkey experience from concept through post-market launch. To learn more about the ICP please contact susan@jgsgroup.com.

 

Jen Murray CEO
Jen Murray, CEO
Jen has been at the forefront of the reimbursement industry for more than 23 years and is the founder of the JGS Group, Inc., a full-service reimbursement consulting group. Since 2001, JGS has provided reimbursement consulting for new and innovative technologies ranging from start-ups to Fortune 100 companies. Prior to launching the JGS Group, Jen held several positions at Covance. She has served as Covance’s representative for the National AIDS Advocacy Program, working directly with the Clinton administration on the Ryan White Fund, an initiative to secure alternative funding for AIDS/HIV patients. Jen has authored various articles on reimbursement-related issues in such publications as the FDANews, Medical Device and Diagnostics Manufacturer’s Magazine, and Drug Information Association News. She has spoken at conventions and workshops all over the world. She was appointed to the FDA News Advisory Panel in 2003 and is currently serving on the Board of Maryland Innovations Initiative (MII). Jen holds a Bachelor of Arts in Sociology and Psychology from Villanova University.

JGS Group

Jennifer Murray – President and CEO

jmurray@jgsgroup.com

703-622-3465

JGS Group © 2020