REGULATORY SUBMISSION
Based on the application strategy and documents you have, we support preparation of application forms and technical documents, submission preparation, and responses to review inquiries: questions from PMDA or a Registered Certification Body during review. You can engage us after document preparation has started or solely for responses to inquiries received after submission.
Where the application pathway or evaluation approach needs consideration, we review the application strategy and required evaluations before preparing the documents.
We compare the content of the application form, test reports, clinical evaluation, QMS documents, and statutory labeling, then define the work required before submission.
We divide responsibilities with the applicant, such as the Marketing Authorization Holder, and support document preparation and submission readiness. Because the documents and procedures differ among approval, certification, and marketing notification, we do not apply the same work to every product.
We confirm the application category and current preparation requirements and organize the application form, technical documentation such as the STED, Essential Principles conformity checklist, test reports, and clinical evaluation. After submission, we prepare draft responses and supporting documents according to PMDA's questions.
We confirm the applicable certification standard and product scope and organize the certification application documents, evidence of conformity with standards, and QMS documents. We also support responses to questions from the Registered Certification Body.
We confirm information such as the Japanese generic device name, product name, intended purpose, product configuration, and manufacturing sites, and support preparation of the notification. We do not treat notification as the same procedure as an approval or certification review; we confirm the requirements applicable to the product.
We check that the intended purpose, target patients, models, sizes, and accessories in the application are consistent with the supporting documents.
We check whether the tested product represents the products in the application and whether the test methods and acceptance criteria support the claimed performance.
We check the relationship among methods of meeting each requirement, risk-control measures, warnings, and precautions. We consider the content of package inserts and instructions for use in light of the requirements applicable to the product.
When clinical study results or a Clinical Evaluation Report (CER) are used, we check that the evaluated product, intended purpose, comparator, and conclusions do not conflict with the other application documents.
We compare the manufacturing sites and processes stated in the application with registrations, quality documents, and QMS materials. If a QMS conformity assessment is required, it is addressed in parallel with application preparation.
Based on the application strategy, documents already prepared, testing progress, and consultation results, we list missing documents, responsibilities, and work required before submission.
We prepare the application form and supporting documents and check for inconsistencies in terminology, specifications, manufacturing sites, document numbers, and versions. We identify matters the applicant must confirm and compile the submission package.
We confirm the submission method and required documents and support submission readiness. During review, we set out how to answer each question, which documents support the answer, and where the application documents need revision.
We check that statutory labeling, quality documents, and product information are consistent with the approved, certified, or notified content. If changes arise after launch, the necessary regulatory procedure and documentation are considered separately.
For questions from PMDA or a Registered Certification Body, we organize the following information:
Matters requiring additional confirmation are separated, and a consistent response is prepared across the full application dossier.
If the Japanese generic device name, application pathway, comparator, or testing and clinical evaluation approach has not been determined, you can begin by consulting us on the application strategy.
Yes. We review the documents already prepared and list the work to be taken over, missing documents, and sections requiring revision.
Yes. We compare the questions with the documents already submitted and agree with you on our tasks, such as drafting responses or organizing supporting documents.
It may be usable. We check its relationship to the product scope, intended purpose, and test conditions in the Japanese application and specify where further explanation or documentation is needed.
Yes. You can discuss the required scope, such as the STED, Essential Principles conformity checklist, or clinical evaluation. We may ask to review related documents so consistency with the rest of the application can be checked.
CASE STUDIES
Client names and product details remain confidential. Each case distinguishes the work performed from the confirmed outcome.
Approval obtained
A case covering submission documents, evaluation planning and coordination for a pancreatic duct stent that obtained marketing approval.
CER revision and response drafts completed
Case study of CER review and PMDA inquiry support for a medical device application in Japan, including evidence gaps and response preparation.
Share the expected application pathway, document readiness, target submission date, and the support you need.
Discuss submission preparation and inquiry responses