CXMJ will provide regulatory support including domestic and overseas administrative trends such as phamaceuticals, medical devices, clinical research, marketing and clinicl development.
CXMJ proposes optimal solutions based on the client’s intention based on the latest information such as trends of industry companies by country/region, development trends of new drugs/new medical devices globally after marketing.
With an emphasis on speed, and cost, CXMJ will support the medical industry by our experienced experts.
In addition, CXMJ will support detailed tasks such as preparation of safety information report necessary for promoting clinical development, call center work, case reporting file preparation, investigational drug transport management work, etc.
Covering area of CX Medical Japan
- Pharmaceuticals, Medical devices, External diagnostics, Regenerative medical products, and Health Foods etc. related to clinical development or clinical research.
- Domestic market survey by pharmaceutical region, market survey in Asia, Europe and the United States.
- Preparing development plans by therapeutic regions
- PMDA Consultation, Consultation material preparation, Overseas business administrative information service, International QA matters support.
- International safety information preparing support
- Clinical development
- SMO operations
- New QMS compliant procedures(November 2015. NEW!!)
Professional features of CX Medical Japan
- CXMJ specialists will help you at each stage in each area.
- We will provide business information on the latest of Asia/Global status.
- We will respond promptly and report periodically.
- We will respond with clear and affordable consulting fee standards.
|Type of industry||Contents|
|Medical devices||Medical device insurance inventory support|
|Magnetic equipment manufacturer||Manufacturing permission, QMS survey support response,magnetic testing equipment certification application|
|Management consulting||Manufacturing permission under the revised Phamaceutical Affairs Law, support for response to QMS survey|
|Electrochemical manufacturer||Manufacturing permission under the revised Pharmaceutical Affairs Law, support for response to QMS survey|
|Medical welfare equipment makers||Examination and diagnosis equipment Pharmaceutical consultation|
|Regenerative medical venture||Developmental consulting for regenerative medical venture|
|Industrial rubber manufacturer||Acquistion of suture certification for veterinary use, QMS survey support|