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Consulting Achievements

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Japanese companies, etc.

Overseas Development Support

  • We provided support for overseas development strategies, overseas expansion plans, clinical development plans, etc. for Japanese pharmaceutical companies and venture companies entering overseas markets.
  • We searched for experts, contacted, visited, and interviewed experts in the development regions (Europe and the U.S.).
  • In the U.S., we prepared materials for consultations with the FDA (Pre-IND meetings), participated in the meetings (EOP2, Type C meetings etc.), prepared minutes, and communicated with the authorities with local regulatory consultants.
  • In the U.S., we selected CROs for clinical trials, secured storage space for investigational drugs, set up development project teams, and managed clinical trials (including CRO management). The project team included a U.S. medical consultant.
  • We prepared and filed IND application materials in the U.S. and communicated with the regulatory authorities with the local medical consultant IND is filed in e-CTD format./li>
  • In clinical trials, we provided support management for Phase 1, Phase 2, and Phase 3 trials. We supported the evaluation of safety information (e.g., SAEs) and sponsor decisions during clinical trials.
  • Prepared for meetings with regulatory authorities during clinical development (e.g., preparation of materials, questions, etc.) Participated in meetings.
  • In response to “Request for Information” and “Clinical Hold” orders from the FDA during clinical trials, we conducted related investigations and prepared response materials with local consultants to restart the clinical trial.
  • After the completion of the clinical trial, we supported the application for Market Authorization (NDA/BLA) and responded to inquiries from the regulatory authorities with the help of local consultants.

General Clinical Development

  • We assisted a venture company in establishing an overseas development strategy and clinical development plan.
  • We provided support to foundations for international joint research.
  • We provided support for clinical trial data management to venture companies.
  • We provided support to a venture company in the preparation and execution of procedures for transferring clinical trial-related data from a CRO, and in data storage.

Drug Discovery Support

  • We evaluated candidate compounds for drug discovery for pharmaceutical companies newly entering drug development.
  • We provided initial evaluations of in-licensing candidate compounds for investment funds.
  • We were involved in determining compounds to be developed by pharmaceutical companies.
  • Assisted in the compilation of preclinical studies conducted in academia, maintenance of records, and preparation of reports.
  • We helped drug discovery ventures develop the development plans necessary to initiate clinical development and identify data to be obtained before the start of clinical trials.
  • We also performed a Gap Analysis to assess whether a bio-venture planning a clinical trial has all the necessary studies to file an IND application.

Alliances

  • We provided seed search support, alliance planning support, and alliance proposals among venture companies.
  • We assisted in the design of a development department for a joint venture between pharmaceutical companies and in the formulation of a recruitment plan.

Sales and Marketing Support

  • We assisted the verification of pharmaceutical sales situation and review of sales strategy.
  • We reviewed potential partner companies for pharmaceutical sales cooperation.

CMC and regulatory affairs support

  • Proposed answers to questions from regulatory authorities regarding the nature of investigational drugs.
  • Provided answers to questions from regulatory authorities regarding changes in manufacturing sites, etc.
  • Prepared and proposed responses to inquiries from regulatory authorities regarding application materials.
  • We prepared standard operating procedures (SOPs) for holding a double-blind evaluation committee meeting.
  • We verified the GMP manufacturing documentation system for venture companies and pointed out excesses and deficiencies in SOPs.

Overseas companies, etc.

Research on the Japanese market

  • At the request of an overseas investment bank, we conducted research, comparisons, and future market analysis of products developed in the Japanese market.
  • We conducted interviews with Japanese experts and conducted Japanese patent searches for foreign pharmaceutical companies.
  • We conducted a survey on the development status of competing drugs in Japan for foreign bio-ventures. We also proposed the outline of a plan for development in Japan.

Support for Development in Japan

  • We provided support to an overseas pharmaceutical company on regarding a survey of clinical trials required in Japan and an outline of a clinical development plan.
  • We assisted an overseas pharmaceutical company to consider Japanese development partners.
  • We conducted a survey of Japanese medical experts for an overseas venture company and suggested candidates for Key Opinion Leader (KOL) positions.
  • We proposed to an overseas venture company the outline of a strategic development plan for the development in Japan of a compound that had been developed earlier in other countries.

Alliance Support

  • We assisted an overseas pharmaceutical company to disclose information to a Japanese pharmaceutical company.
  • We set up a data room for overseas bio-ventures to view data held by Japanese ventures, established a system to provide information, and managed and operated the actual data disclosure.
  • We prepared materials to explain to overseas bio-ventures and provided explanations on their behalf.