We offer integrated solutions concerning Clinical Trials, Pharmacovigilance(PV),
Regulatory affairs, Pricing & Reimbursement, Market Research, distribution and logistics.
As a consulting group with more than 15-year track records 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 records in paving new ways creatively for clinical studies of innovative therapies with government authorities, IRBs, investigators and patients.
CRO for Regulatory Processes of Innovative Therapies
Accountable Project Management
Flexible Budget Models
Experiences in Diverse Therapeutic Areas
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.
Individual Case Safety Report (ICSR) Processing
Risk Management Plan (RMP)
Drug Safety Information Assessment
Customized Development of PV SOP
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.
Up-to-date Intelligence on MFDS Regulations
In-depth Communications with Customers and Regulatory Bodies
Efficient Problem Solving
Concerted Strategies Pricing and Reimbursement (P&R)
Experiences in a Wide Spectrum of Therapeutic Areas and Regulatory Issues
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.
Reimbursement Strategies Aligned with Up-to-date Government Policy
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.
Quantitative Research Based on National NIH Claim Data
Reality Checks with Korean Business Experts
Qualitative Research through Wide Access to KOLs
Advices on Market Access Strategies
Distribution Partnership Options
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.
Faster Market Access
Multiple Distribution Partnerships
Perfect Replacement of Your Subsidiary in Korea