A Holistic Approach: JGS is a strategic clinical, regulatory and reimbursement consultancy for MedTech and Life Science. We uniquely combine programs for development, implementation and commercialization. With our capacity to execute your customized commercialization plan, we 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
-Customized reimbursement assessment
-Comprehensive competitor analysis including a clinical literature review and evaluation
-Comprehensive payer analysis (Medicare and Medicaid)
-Investor due diligence evaluations
-Pricing and reimbursement rates
-Clinical protocol reviews
-Strategic reimbursement planning
-HCPCS/CPT/PLA code applications
-Coverage policy review
-Reimbursement call center services
-Claims submission assistance
-Specialized claims submission
-Patient Assistance Programs/Compassionate Care Programs
-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-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
-Clinical trial design
-First-in-Human and Early Feasibility Studies
-Analytic and biometrics
-Site initiation and management
-Data file management
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 email@example.com.