Services and Solutions

All efforts for patoents,All professional works for clients ライフサイエンス分野のプロフェッショナルとして、高品質で専門的なサービス・ソリューションを提供し、医薬・医療の発展と人々のQOLの向上に貢献します。

Rapid access to Japan/Taiwan market entry.

– Comprehensive regulatory consulting and navigation, providing fastest pathway to NDA
Best in class clinical study performance
– Our goal is your goal

A2 Healthcare (A2) will support you by guiding how you can bring your drug to market in this region. With 1,200 experts, A2 is a top tier CRO for supporting foreign pharmaceuticals and biotechs to realize Japan/Taiwan development.

Expertise in Regional Regulations:

A2 possesses deep knowledge and experience of regulatory requirements and processes specific to Japan and Taiwan pharmaceutical market. We are up to date with the latest regulations issued by the authorities. We will provide regulatory support under accurate and current guidance and bring the best solution that algins to your corporate development plan.

Providing Regulatory Consultation:

Developing an effective regulatory strategy is such a key factor for successful drug development. Our regulatory experts will evaluate your product’s regulatory requirements, perform gap analysis, and provide strategic advice in each step. We will prepare, coordinate, and assist you on authority meetings such as pre-consultation and main consultation meetings (PMDA/TFDA meetings).

Conducting Clinical Trial:

Despite all the regulatory process to start a study, it is still incredibly challenging for a foreign company to conduct a study in this region, especially for Japan to align to its local requirements. A2 will provide comprehensive support and management throughout this entire clinical trial process.

  • – Identify KOLs and patient location
  • – Managing IRB process and site initiation
  • – Boost the rate of patients’ enrollment
  • – Obtain high quality data among the clinical sites throughout the study
  • – Function as your legal representative (ICCC: In Country Clinical Caretaker)

A2’s goal is your goal

It is especially important for us to understand your drug and development plan to achieve your goal. We will ask you for close communication and set a mutual goal. Our ultimate mission is to bring new treatment to the patients together with you. Please contact (Contact us – A2 Healthcare Corporation) to discuss how we can support you to accelerate your drug development in this region.

New Drug Development

  • Monitoring
  • RBM
  • Data Management (DM)
  • eSubmission (eCTD/CDISC)
  • Clinical IT Solutions
  • Statistical Analysis
  • Medical Writing
  • Pharmacovigilance
  • GXP Audit
  • Regulatory Support
  • Medical Experts
  • Clinical Pharmacology
  • Clinical Research/Investigator-Initiated Clinical Trials
  • Oncology Drug Development
  • Embelied solutions
  • Project Management
  • SMO & Vendor Management

A2 Healthcare has deep experience in Post-Marketing Surveillance (PMS) and RWE solutions as well.

Post-Marketing Surveillance

  • Patient Enrollment
  • Data Management (DM)
  • Statistical Analysis
  • Medical Writing
  • Pharmacovigilanc
  • PMS Support
  • Clinical IT Solutions

In addition, we proactively support the development of medical devices, cellular and tissue-based products, vaccines, etc. through our dedicated department to provide wide range services responding to recent medical and social needs.

Medical Device Development

Development of cellular and tissue-based products

Vaccine Development

Global Development

Clinical Research

Generating Real-World Evidence

Patient Centricity