Japan has specialized regulatory requirements.

IDEC provides specialized solutions and services.

IDEC is a globally-minded, bilingual consultancy with regional expertise in the Japanese pharmaceutical market. Our applied regulatory experience and our ability to partner and communicate with Japan’s local constituents makes IDEC a consulting firm that is unrivaled in its ability to support your path to market while adding value every step of the way.

If you’re ready to learn more, we’re here.

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IDEC takes a proven, four-step approach to regulatory strategy, development, implementation, submission, and go-to-market. This is our precise regulatory pathway.

Step 1 Identify Establish Strategy
STEP 1

Identify & Establish Strategy

IDEC assesses and clarifies all opportunities and risks associated with your drug product’s development as we establish an appropriate strategy.

Our process includes:

  • Initial Assessment
STEP 2

Confirm Strategic Development

We will meet with Japanese regulators on your behalf to confirm development strategies and requirements.

Our process includes:

  • PMDA Consultation
  • Potential Strategic Alternatives
Step 2 Confirm Strategic Development
Step 3 Implement Strategy
STEP 3

Implement
Strategy

IDEC will commence Japanese development with in-house and virtual resources, and we will perform enhanced licensing negotiations on your behalf.

Our process includes:

  • License Program
  • Commence Development
  • Potential Strategic Alternatives
STEP 4

Steward Submission & Market Entry

IDEC will prepare and submit your J-NDA package through to review and approval. Once secured, we will partner with local constituents to bring your drug product to market.

Our process includes:

  • Application Preparation
  • Application Submission
  • Review J-NDA
Step 4 Steward Submission & Market Entry

Learn more about how IDEC can serve you.

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Development Strategy Planning

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Regulatory Consultation

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Clinical Development Advisory

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Non-clinical Development Advisory

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CMC Advisory

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Application Preparation & Submission

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KOL Management

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Market Entry Planning

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Japanese Market Alignment

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