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 your drug to market in this region. With 1,200 experts, A2 is a top tier clinical CRO working with foreign pharmaceutical and biotech companies on their Japan/Taiwan development.
Expertise in Regional Regulations:
A2 possesses deep knowledge and experience of regulatory requirements and are up to date with the latest regulations issued by the authorities. We will provide regulatory support under accurate and current guidance and propose the best solution that algins to your corporate development plan.
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 are cleared to start, it is still challenging for a foreign company to conduct a study in this region alone without selecting a right partner. A2 is proud that we are the best CRO in this region on our performance and will provide comprehensive support and management throughout the entire clinical trial. A2 has an outstanding 95% compliance rate for keeping the enrollment timeline agreed with our sponsors.
- – Identify KOLs and patient location
- – Managing IRB process and site initiation
- – Boost patient enrollment
- – Obtain high quality data 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 development plan to achieve your goal. We will ask for close communication to set a mutual goal between us. Our ultimate mission is to bring new treatment to the patients together with you and “Our goal is Your Goal”.
Please contact (Contact us – A2 Healthcare Corporation) to discuss how we can support your drug development in this region.
Services A2 Provide
- Clinical Monitoring
- RBM
- Data Management
- Statistical Analysis
- eSubmission
- Medical Writing
- Pharmacovigilance
- GXP Audit
- Regulatory Support
- Medical Experts
- Clinical Pharmacology
- Clinical Research/Investigator-Initiated Clinical Trials
- Project Management
- SMO & Vendor Management
- Post-Marketing Surveillance
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.
