A One-Stop Service for Japan Market Entry

Speed and Quality

Trinity’s experienced consultants’ results-focus expedites the:

• assessment, proposals and advice, assistance for Regulatory Consultation with PMDA, Orphan Drug Designation Consultation, and Package Insert preparation necessary to create your Development and Regulatory Strategy Plans;
• time line planning, Clinical Trial Notification, Application for INN/JAN, Approval Application, Common Technical Document preparation and Quality Assurance assistance for your NDA Submission;
• Assistance for Foreign Manufacturer Accreditation, Basic Plan and Protocol for Post-marketing Surveillance, Regulatory Communication, Compliance Inspection, CTD Revision and Review Report assessment key to your Marketing Approval;
• LCM proposal, assistance in preparing Partial Change Approval Application, Re-examination Application, advice on patent terms, re-examination period, and CTD masking, additions of Indication/Dosage & Administration, New Administration Routes and Dosage Forms, notification of Change in Package Insert, ADR Report and Periodic Safety Update Report fundamental to your Life Cycle Management.

Value

Our consultations understand that Speed + Quality = Value. For you, leveraging Trinity’s virtual-branch-office with our one-stop, end-to-end strategy and operations service, frees up valuable capital to invest in other areas of your pipeline

Trinity: Excellence, Partnership and Results-focus

With Trinity as trusted advisors, you save on the anxiety normally associated with entry into this exacting market, and can avoid forfeiting value to a local licensing or distributorship agreement.

• Our consultants have decades of pharmaceutical regulatory affairs experience, dealing with PMDA and MHLW on behalf of both domestic Japanese and foreign-capital companies.
• Starting with the end in mind: successful approvals with your company’s scientific data, these experts collaborate closely with your teams to craft bespoke development and regulatory strategies to deliver fast, high quality, cost-effective product commercialization.
• You have full consulting and operations support for regulatory consultation, NDA submission, regulatory communication, and post-approval/marketing life cycle management of generics and new drugs, including chemical compositions and biopharmaceuticals.

Let Trinity be your virtual branch office in Japan to fully leverage the opportunities this unique and potentially lucrative market offers for your innovation.