Our Services

In order to enable our clients to take strategic decisions regarding new opportunities in Japan, IDEC provides its services in a stepwise fashion, with clear deliverables. For clients who are already in Japan and have specific needs for professional support, we will tailor our services and organize a team to help address these requirements.

Step1:Clarify the Opportunity / Risks|Initial
Assessment||Step2:Confirm the Strategy|PMDA Consultation ||Step3:Implement the Strategy|Review Other Commercial Options | Commence Development for Japan ||Step4:J-NDA Submission|Preparation / Submission of J-NDA

  1. GoalsBenefits

    • Leverage IDEC’s expertise to clarify opportunities / risks
    • IDEC to conduct a thorough desktop assessment with existing data and IDEC intelligence
  2. GoalsBenefits

    • Confirm development requirements for Japan through a meeting with Japanese regulators, and establish a clear basis for decision making
    • No fixed resource commitments in Japan
  3. GoalsBenefits

    • Commence Japanese development with in-house resources, or virtually in partnership with IDEC
    • Enhanced licensing negotiation position through a confirmed development plan
  4. GoalsBenefits

    • IDEC can lead the preparation of the J-NDA package
    • IDEC can also manage the query process during regulatory review