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Pharmaceuticals

We offer integrated solutions concerning Clinical Trials,
Pharmacovigilance(PV), Regulatory Affairs,
Pricing & Reimbursement,Market Research, distribution and logistics.

Overview

As a consulting group with more than 22-yeartrack record in regulatory affairs in both pharmaceuticals and medical devices, we are unique in bringing our customers clarity, quality, and success in regulatory processes for clinical studies, especially when you have innovative ideas to bring to patients and need to convince government authorities of a new concept of study design, an innovative mode of action, or a new interpretation of regulation.

At Synex, we have proven track recordsin paving new ways creatively for clinical studies of innovative therapies with government authorities, IRBs, investigators, and patients.

Customer Value

  • CRO for Regulatory Processes of Innovative Therapies

    • -CRO Pioneer regulatory processes for innovative therapies, such as, combination products, regenerative medicines, etc.
    • -Provide a full scope of services for clinical studies from Phase I to IV and various forms of post-market studies
  • Accountable Project Management

    • -Assign staff to maximize her/his focus on the study
    • -Operate a cross-functional team for a study and ad-hoc backup system
  • Flexible Budget Models

    • -Offer diverse budget models to tailor to different needs of customers
    • -Listen customers to their budget constraints and work out a creative win-win solution
  • Experiences in Diverse Therapeutic Areas

    • -Provide in-depth insights and broad networks from our experiences in a wide spectrum of therapeutic areas
    • -Share with customers strategic issues that need to be addressed in order to avoid potential problems specific to the study
  • In-Depth Communication

    • -Communicate closely with customers throughout the entire process of study from regulatory submission and startup to closeout
    • -Provide a role as a proactive center of communications among sponsor, investigators, IRB and government authorities

Overview

The Korean Ministry of Food & Drug Safety (MFDS) has raised dramatically the level of pharamacovigilance (PV) requirements in recent years. Understanding the regulation and establishing your system for compliance has never been more important.

Synex has in-depth expertise in PV regulation and managing risk for pharmaceutical products in Korea, especially when the government authorities including MFDS, Ministry of Health and Welfare (MOHW), and Health Insurance Review & Assessment (HIRA) Service are involved. We know how the government tracks and monitor drug safety throughout its life. We can tell you the Korean government's viewpoints. We can help you with compliance with PV regulation and crisis management effectively and efficiently.

Customer Value

  • Quality Support

    • -Set up and advise for operating PV systems on ICH / MFDS guidelines
    • -Provide services compatible with global standards
  • Individual Case Safety Report (ICSR) Processing

    • -Prepare case reports in the council for International Organizations of Medical Sciences (CIOMS) or MFDS forms
    • -Process cases and submit reports according to timelines required by companies or MFDS
  • Risk Management Plan (RMP)

    • -Develop RMP to meet with MFDS regulation and expectations
    • -Advise to execute RMP aligned with MFDS expectations
  • Drug Safety Information Assessment

    • -Assess AE & ADR and determine appropriate reporting pathways through full lifecycle of drug
    • -Provide in-depth safety assessment in cooperation with internal regulatory experts, medical writer and data manager
  • Customized Development of PV SOP

    • -Develop SOPs for product type and organizational structure
    • -Train PV staff

Overview

At Synex, our consultants have multiple years of experience in diverse regulatory disciplines spanning from pre-market approvals and post-market management and are respected by the regulatory body for the high level of knowledge, experience, integrity and commitment to our customers.

We develop preemptive solutions for potential regulatory hurdles and ensure the quality of submissions to the government agencies to maximize the likelihood of successful review.

Customer Value

  • Up-to-date Intelligence on MFDS Regulations

    • -Regulatory consulting aligned with global standards
    • -Provide win-win solutions filling out the gaps between MFDS and customers
  • In-depth Communications with Customers and Regulatory Bodies

    • -Set up communication processes to work with regulatory information systems of global pharmaceutical companies
    • -Efficient communication with reviewers and timely updates with customers on the status of progress
  • Efficient Problem Solving

    • -Assign a dedicated consultant for each project
    • -Provide early warnings of potential problems and propose problem-solving scenarios
  • Concerted Strategies Pricing and Reimbursement (P&R)

    • -Execute regulatory strategies aligned with P&R strategies
    • -Minimize time to market through parallel process
  • Experiences in a Wide Spectrum of Therapeutic Areas and Regulatory Issues

    • -Experiences in a variety of drugs in diverse therapeutic areas
    • -Proven track records in successful approvals of innovative drugs

Overview

Korea has the public health insurance called National Health Insurance (NHI. It is a compulsory program requiring all citizens for contribution and healthcare providers for price controls and reimbursement. Having reimbursement approval from NHI at reasonable price is the only way for drug business expansion in Korea.

Synex provides our expertise for reimbursement approvals of new drugs from NHI. We prepare applications and lead our customers to efficient communication and negotiation with review or negotiation bodies under NHI. By combining lobbying efforts with our contacts, we assist our customers in enhancing the ability of successful reimbursement approvals and pricing.

Customer Value

  • Reimbursement Strategies Aligned with Up-to-date Government Policy

    • -Provide strategic advices for successful reimbursement approval reflecting up-to-date government policy
    • -Advise of pricing options and pathways for different business strategies
  • Quality Application

    • -Draft reimbursement applications presenting robust rationales and supportive evidence
    • -Assist in developing an economic evaluation report supporting reimbursement applications
  • Risk-Share Arrangement

    • -Work out options for risk-share programs and budget impact analysis
    • -Provide consulting to shape a risk-share program and agree with government
  • Price Negotiation

    • -Advise price negotiation strategies and tactics
    • -Provide consulting to deal with government perspectives and rationales
  • Expert Communication

    • -Monitor review process and advise of communication strategies in a timely manner

Overview

Market research is essential for decision making for new entry into the healthcare business.

Synex designs and offers goal-oriented research method for clients interested in Korean healthcare market. We not only gather market data such as analysis of competitiveness among products, distribution channel or success/failure factors of specific products etc. through in-depth interviews with experts such as clinical doctors, medical institutions, and regulatory agencies, but also develop insights to make an informed business decision. With the report we provide, customer is able to make clear decisions on the concerned business.

Customer Value

  • Quantitative Research Based on National NIH Claim Data

    • -Process big data from national NIH claim data to customize information for business interest
    • -Analyze and interpret the information to understand market dynamics
  • Reality Checks with Korean Business Experts

    • -Interview business experts of extensive experiences in relevant market segment
    • -Find out lessons from previous success/failure cases
  • Qualitative Research through Wide Access to KOLs

    • -Interview doctors, nurses, and technicians to obtain end-user views
    • -Discover requirements of end-users to create business opportunities
  • Advices on Market Access Strategies

    • -Provide advices on business model, product portfolio, distributorship options, etc.
    • -Suggest reimbursement and regulatory strategies optimized to market entry
  • Distribution Partnership Options

    • -Recommend options on distribution models
    • -Search qualified distributor candidates matching customer’s criteria

Overview

Under In-Country Caretaker service, Synex acts as your total business representative in Korea. Through the ICC Service model, the foreign manufacturers are able to set up a legal entity that has similar characteristics as branch without much initial investment while the distributor is able to concentrate on sales and customers by escaping from the duties such as strict product registration & license management or reimbursement, etc. to lead an even more effective business structure.

Customer Value

  • Faster Market Access

    • -Register products and select distributors in parallel
    • -Set up business models with Synex experts in multiple disciplines
  • Multiple Distribution Partnerships

    • -Work with a multiple number of distributors or sales agents
    • -Flexible to change/expand sales channel without license issue
  • Business Safety

    • -Secure the actual ownership of product license
    • -Product license management with high level compliance
  • Reasonable Fees

    • -Flexible service fee based on business scale, import volume and revenue
    • -Provide various options for logistics fee
  • Perfect Replacement of Your Subsidiary in Korea

    • -No capital investment to set up a legal entity
    • -No need to hire RA/QM/PV manager and supply chain manager
    • -No need to rent office and warehouse space