Regulatory Consultation

Complying to regulatory requirements is the gateway to local markets everywhere in the world, and Japan is no exception. We help our clients take a comprehensive view of the local regulatory environment and help them put together the most efficient approaches to approval.

Gap analysis

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Laying out paths and timelines

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Preliminary dialogues with regulatory officials

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Applicability assessment of timesaving development programs

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Business impact analysis of regulatory alternatives

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Case

Validation of Clinical Development and Pricing Strategy

A German-based biotech in discussion with a Japanese company about the potential licensing of its product. The product targets the treatment of a disease with large unmet medical need currently receiving little treatment.
The product was finishing its Phase III program in Europe with plans to submit the application for approval to the authorities.

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Evaluation of Clinical Value Over Competitors

Swiss-based pharmaceutical company seeking business opportunity to develop their product in Japan. Competitive products for the same disease already existed in the Japanese market. Client needed to assess the clinical value of their product and its potential to succeed in Japan, including any advantage over competitors.

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Gap analysis

Utilizing existing data in the NDA is an effective way to meet the local standards. We carry out gap analyses in order for our clients to understand the requirements which could be filled with documents already prepared for other applications and those which need to be created.
This is particularly important when clients are using bypassing methods in their own markets, such as the 505 (b)(2) pathway for FDA approval.

Laying out paths and timelines

Designing a local clinical development process aligned with the global plans is a complicated task which requires a recognition of when certain information becomes available from the global end, which a local task may have dependency with.
In our planning process, we make sure that all the tasks and processes are streamlined and map out the entire project flow to visualize where the key bottleneck process is.

Preliminary dialogues with regulatory officials

In the complex world of local clinical development, it is always helpful to get official/unofficial advice from the field in order to navigate through with your project.
We can help our clients get the sense about what is acceptable and what is not in your development plans, which will sometimes save you more time in making strategic decisions.

Applicability assessment of timesaving development programs

Various regulatory paths are prepared to expedite the development of drugs with cutting edge innovation expected to solve diseases with high unmet medical need. Those include

  • Priority review system: applies to drugs recognised as clinically important
  • Restrictive approval system: in case of emergencies (e.g. COVID-19)
  • Orphan drugs: drugs treating diseases with the number of patients less than 50,000 and with expected clinical usefulness
  • Drugs of pediatric use
  • Unapproved Drugs and Drugs of Off-label Use: for drugs not yet approved but with high unmet medical need
  • SAKIGAKE: innovative products expected to launch first in Japan

e-Projection can give advice to clients willing to gain further information to seek for the applicability of these programs to their own drug development plans.

Business impact analysis of regulatory alternatives

Combining these regulatory assessments with our valuation capabilities, we can offer our clients a multiple regulatory scenario based business planning model in order to understand the differences in the project valuation and its risk, in other words the probability of success, across the scenarios.

We help non-Japanese pharma/biotech companies
understand and expand into the Japanese market.