Since its founding 3 years ago, IDA has developed a broad range of experience in all of its service areas.
Strategic and Commercial Support
IDA's clients consist of small to mid-size pharmaceutical companies seeking to develop a Japanese market entry/partnering strategy. Thus we provide them with a strategic assessment of their product within the Japanese commercial, medical, and drug development environment. We also ensure that the expert services we provide are fully integrated with our clients' larger strategic and commercial goals.
Product Development Services
IDA has undertaken expert consulting programs and prepared Development Plans for Japan in wide range of therapeutic areas including:
- Ophthalmology (Dry Eye)
- CNS (Insomnia)
- Oncology (Prostate Cancer 2)
- Urology (Enuresis & Nocturia)
- Hepatitis B&C
- OA/Pain
- Dermatology
- IDA was responsible for the strategy development and execution of a PMDA consultation for insomnia and successfully obtained the endorsement of a bridging approach in CNS.
- IDA has a wide range of experience in managing regulatory strategies and informal and formal consultations in the following therapeutic areas:
- CNS/ Insomnia
- Anti-infectives
- OA/Pain
- Oncology
- IDA has prepared and filed CTNs on behalf of a foreign company and currently serves as the Clinical Trial In-Country Caretaker for an insomnia development program.
IDA has undertaken a unique collaborative approach to implementing Phase II-III insomnia trials. The approach is explained in more detail under Partnerships.
