IDEC has been in service since 2003 and has ever since provided biotech and pharma companies all over the world with strategic advice to obtain regulatory approval for, and successfully commercialize, their products in Japan with minimum "drug lags," risk, and overall costs. Our team consists of experts of filling gaps; we are professional strategists. As we know each day saved means many patients saved, we use the fullest of our capabilities to efficiently start your process. *IDEC’s main services include: - Strategic: Japan Development Plan, Japan Market Strategy, Japan Licensing Strategy, KOL mapping - Regulatory: CMC gap analysis, PK-PD ethnic assessment, PMDA consultation, CTD creation, J-MAA - Commercial: market access consultation, licensing matchmaking and negotiation, KOL management * Why Biotech/Pharma Companies Count Japan In? As you know, Japan is the 3rd largest market of the world, of about USD 100 billion, after the US and China. Besides its size, Japan has a great environment which makes this country even more attractive: - High and stable, government-controlled drug prices - The Japan National Health Insurance to cover everyone’s medical expenditures - Policies and programs to protect and privilege innovative drugs - ICH membership for simultaneous trials *IDEC Should Assess Your Drug Now? The ICH Committee encourages sponsors to communicate with the PMDA to determine whether their planned programs will address the requirements of Japan. Below are the reasons you should have us assess your product now: - You can start with a minor cost - You can make use of IDEC’s expertise and experience as though it’s part of your team - The PMDA tends to be less demanding with simultaneous trials than it is with bridging studies - IDEC is willing to bring up all risks and predicable scenarios at the opening phase, when the foundation of the years-long course of action is built. For more details, inquire us at: http://www.idec-inc.com/En/contact/