meditip

Product Commercialization Support

Commercialization Support for R&D Products

From identifying R&D projects in healthcare fields such as pharmaceuticals and medical devices to approval, reimbursement, market entry, and overseas expansion, Meditip provides strategic support services across the entire product commercialization cycle.

Product Commercialization Support Areas

  • R&D Project Discovery and Planning

    We support the discovery of R&D projects and early planning strategies that consider marketability and development feasibility.

  • R&D Activity Research and Analysis

    We analyze technology trends, the competitive landscape, and development risks to present the optimal development direction.

  • Commercialization of Core and Industrial Technologies

    We establish commercialization strategies so that proprietary technologies translate into actual products and business results.

  • Overseas Market Entry Promotion and Support

    Through global regulatory approval and partner discovery, we support entry into and expansion within overseas markets.

Commercialization Support Roadmap

From product discovery through nonclinical, clinical, approval, reimbursement, and market entry, we support successful commercialization with stage-by-stage strategy and execution.

Discovery

Development

Commercialization

Pre-Clinical

Formulation · Nonclinical Consulting

Formulation and Non-clinical Consulting

In the early product development stage, we support the establishment of formulation strategy, CMC, and non-clinical development direction, as well as pre-clinical data review through CRO collaboration.

  • Formulation / CMC Strategy

  • Non-clinical Development Plan

  • Pre-clinical Protocol Review

  • CRO Collaboration

  • Non-clinical to Clinical Bridging Review

Clinical Trial I, II, III

Clinical Development · CRO Management

Clinical Development and CRO Management

From establishing clinical development strategy to IND/IDE approval, CRO operations, and communication, we provide systematic support across the entire clinical trial process.

  • Clinical Development Strategy

  • Clinical Study Design

  • IND / IDE Approval

  • CRO Management

  • Clinical Trial Companion Consulting

Registration

Product Registration · NDA

Product Registration and NDA Strategy

From reviewing approval feasibility to NDA/BLA approval, CTD preparation, and PMS strategy, we support the entire process for successful product registration.

  • Approval Feasibility Review

  • NDA / BLA Approval

  • CTD Preparation and Filing

  • RMP / PMS

  • Registration Strategy Establishment

Marketing

Reimbursement · Marketing

Reimbursement and Market Entry Strategy

From reimbursement listing, HIRA consultation, and market forecasting to License-out and ICC services, we support market establishment and commercialization after approval.

  • Reimbursement and Marketing Strategy

  • HIRA Consultation

  • Market Forecast

  • License-out

  • ICC Services

  • GIP / Import SOP