Beruflich Dokumente
Kultur Dokumente
Market Penetration
Operational Expenses
+
Joint Venture
Share and Board Balance
Transfer Price
Distributorship -
Distribution Strength
Purchasing Commitment
Additional 2 Cs
Cultural Commercial Compliance
Direct Operation Investment Risk Investment Risk Investment Risk
Joint Venture
= =
Distributorship + - +
Basic Model - Kayes View
Cultural
Code of Conducts
Core Value
Direct Communications
Joint
Compliance Venture
Regulatory (PAL)
Pre-clinical (GLP)
Clinical (GCP & GPSP) Capability
Quality (GQP & QMS) Commitment
Vigilance (GVP)
Distributor Channels
Commercial
Seizou-Hanbai Shonin (Market Release Approval)
1. YOUR distributor is the applicant - usual
Apply as the Market release Authorization license Holder
(MAH, Seizou-Hanbai Gyosha) for the product
Changing distributor is a potential challenge as Shonin is
granted to distributor, not YOU
Market Release = To originate Manufacturing, Importation, Distribution, Sale, Rent and/or Present
Lesson 1
Sales
Structure Strategies
Incentives Customer Handlings
Training Customer Segmentation
Marketing
Launch Strategies English Capabilities
Processes Customer Preferences
Product Positioning Market Intelligence
Criteria - Commercial (2)
Workforce Diversity
Age Turnover
Gender Tenure
Supply Chain
Inventory Management Labeling Operation
Dealer Management After Service
Voice of Stakeholders
Customers Regulators
Competitors Present Manufacturers
Dealers Past Manufacturers
Criteria - Compliance & Cultural (1)
Demand and Observe
Alignment on Shonin strategy
Bilateral satisfaction of WHY before any action
Peer review on all documents PRIOR to submission
Participation on all meetings with MHLW/PMDA
Biweekly conference call to align on next step
Quarterly face to face meeting
5 MU
Muri, Muda, Mushi, Muchi, Mura
Overstressed, Waste, Ignorance, Untrained, Non-uniform
5 GEN
Genba, Genbutsu, Genjitsu, Genri, Gensoku
On Site, Actual Thing, Reality, Theory, Principal
Good Preparation (1)
Understand PAL, GLP, GCP, GQP, QMS, GVP and GPSP
YOU need to invest time and money, do your homework to gain access
to attractive Japan market; nothing come for FREE
YOUR overall cost will be higher later, if you compromise now; deal with
it upfront
Quotes
Your most unhappy customers are your
greatest source of learning. - Bill Gates