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.
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
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 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
