(for manufacturers and medical institutions: EU, USA, CIS, Middle East)
JOI Consulting Group can act as a legally competent intermediary/agent between medical device/drug manufacturers and clinics, hospitals, and medical centers. We operate on a retainer + success fee model or a percentage of supply volume, strictly complying with MDR/FDA, GxP, anti-corruption norms, and HCP/HCO interaction rules.
Our Services for Manufacturers:
- Regulatory Strategy and Compliance:
• Preliminary product classification (drug / medical device; risk class);
• Registration roadmap: EU (MDR/IVDR, CE), USA (FDA 510(k)/De Novo/PMA, IND/NDA/ANDA for drugs), CIS/Middle East (national rules);
• Organization of EU Authorized Representative / PRRC, local applicant/MAH, preparation/localization of IFU, UDI/labeling;
• QA/QMS: ISO 13485, GMP/GDP; Quality/Technical Agreement, PV System Master File (for drugs), material vigilance (for devices). - Contractual and Legal Framework:
• NDA, agency/distribution, supply (Incoterms 2020), SLA/service, IP licenses;
• Anti-corruption policy (FCPA/UK Bribery Act), codes of interaction with physicians, advertising restrictions. - Market Access and Commercialization:
• Market assessment and distribution channels, selection and due diligence of distributors;
• Tender strategy, budgeting, pricing, shipping conditions. - Import, Logistics, and Storage:
• HS codes, customs, permitting documentation, temperature regimes, GDP/cold chain SOPs. - Incident Management:
• Handling quality complaints and adverse events/SAE; regulatory notifications;
• FSCA/Recall: recall plan, customer notifications, replacement/disposal;
• Temperature deviations, cold chain disruptions, counterfeits, customs seizures — legal and operational support.
Our Services for Clinics and Medical Institutions:
• Technology selection “per need” with manufacturer verification (ISO 13485/CE/FDA, clinical data);
• Supply contract, warranties/service, staff training, commissioning;
• Post-marketing support: complaints/AE reporting, warranty cases, returns/disposal;
• Tender support and budgeting; SOPs for product/drug handling at the client.
Examples of Products in Our Portfolio:
SmartBone® — composite bone graft (IBI SA, Switzerland)
Purpose: reconstructive/orthopedic and maxillofacial surgery; biomimetic structure for osteoconduction and mechanical strength.
Regulatory status and configurations — per manufacturer’s materials.
Pricing: depends on size/form factor and purchase volume; provided in quotation. Full description and presentation available upon request.
SpinoSave® — specialized hydrogel with autologous cell component (Regenera GmbH, Germany)
Purpose: minimally invasive interventions aimed at restoring intervertebral discs (per manufacturer’s protocols).
Availability and regulatory status — per manufacturer’s dossier and applicable jurisdiction law.
Pricing: determined by manufacturer; provided after specification and volume confirmation. Full description and presentation available upon request.
Important:
Final pricing and supply conditions for both products are determined by specification, volume, logistics, and requirements of the specific country (registration, taxes, certification). We provide personalized quotation after NDA and exchange of regulatory/technical package.
How We Work:
- Manufacturers send us a short dossier: purpose, composition/class, regulatory status (CE/FDA/other), IFU, UDI, certificates (ISO 13485/GMP), clinical materials. NDA signed.
- We conduct pre-due diligence and issue a market entry plan (regulatory, contracts, channels, timelines).
- Agency/distribution agreement signed; KPIs, pricing model, and territory agreed.
- Pilot integrations with clinics launched, training organized, logistics and SOPs validated.
- Post-marketing support, reporting, and incident management carried out.
Legal Disclaimer:
We are not a pharmacy chain/medical organization and do not provide medical activities. Intermediary and legal services are provided in accordance with the laws of the jurisdictions of supply; product/drug registration and compliance with regulators is mandatory. Advertising of medical products is carried out strictly within the legal limits of the respective country.