REGIONAL EXPERTISE, GLOBAL REACH

Accelerate Entry into Japan & Enable
One, Global Path to Market with IDECIDEC’S CAPABILITIESStrategic Counseling• Commercial JapaneseMarket Strategy• Regulatory JapaneseDevelopment Plan
• KOL ManagementRegulatory Services• Regulatory Gap Analysis• PMDA Consulting• CTN Filing• J-NDA/CTD Creation• PMDA/MHLW Consultations• J-MF/CMC Advisory

Commercial Support• Japan CommercializationAdvice• NHI Pricing Advisory• Business Alliance Management• Licensing/Subsidiary Setup

IDEC offers regionally specialized regulatory guidanceand end-to-end drug product support for pharmaceuticalinnovators seeking approval in the Japanese market—thethird-largest in the world. A member of the integrated
family of Validant companies, IDEC enables drug developers
and manufacturers to meet the Japanese market’s uniquerequirements as part of one, global go-to-market approach.
At IDEC, we serve as an external virtual development team forour clients, empowering them to navigate the highly nuanced
requirements of the Japanese systems and regulations. In addition to
our robust service offering, we provide unrivaled bilingual communications,comprehensive project management support, and deep Japanese
regulatory and market expertise.

Gaining Global Access with theValidant Family of Companies
As a Validant Company, IDEC is proud to provide global regulatory
services in collaboration with the Validant family of organizations.
A worldwide provider of regional expertise in regulatory
support, Validant offers drug makers everything theyneed to accelerate entry into the global marketplace,and IDEC is leading the charge in Japan.

Looking to sell your productin Japan? Start here.

Precise Regulatory Pathways,
Proven Market ExpertiseIDEC is a globally-minded consultancy with deep regional expertise in Japan. No other consulting firm offers
the same level of regulatory support with the ability to partner and communicate with Japan’s local constituents.

STEP 1

Identify & Establish Strategy
IDEC assesses and clarifies all opportunities and risks
associated with your drug product’s development as weestablish an appropriate strategy.
Initial Assessment

STEP 2Confirm Strategic Development
We will meet with Japanese regulators on your behalf toconfirm development strategies and requirements.
PMDA Consultation

STEP 3

Potential Strategic Alternatives

Implement Strategy
IDEC will commence Japanese development with in-houseand virtual resources, and we will perform enhanced
licensing negotiations.
LicenseProgram

STEP 4

CommenceDevelopment

Potential Strategic
Alternatives

Japan has specificrequirements—
IDEC provides specificsolutions.
Whether Orphan Drug Designation(ODD), the Sakigake Breakthrough
Designation, or Unapproved Drug
Designaiton, the regulatory experts
at IDEC have navigated all Japaneseapproval pathways. We have
performed FDA- and EMA-related
clinical and non-clinical data anddocument gap analysis to ensure
Japanese requirements are met,and we’ve built strategies forimplementing Japanese requirements
into the global processes of drug
innovators from around the world.

No other regulatory partner
is as well-suited to help
you navigate the Japanese
regulatory landscape.

From Submission to Market
IDEC will prepare and submit your J-NDA package throughto review and approval. Once secured, we will partner withlocal constituents to bring your drug product to market.
PrepareSubmit

Review J-NDA

Streamline your entry into
the Japanese market with IDEC.
Start today by visiting www.idec-inc.com.

Shinjuku i-Land Tower 41F,
6-5-1 Nishi Shinjuku,
Shinjuku-ku 163-1341
Tokyo, Japan
info@idec-inc.com