iCRO is a boutique pharmaceutical regulatory consultancy serving global pharma, biotech, and CGT sponsors entering or scaling in Japan, Singapore, and the broader APAC region. We bring senior PMDA expertise, native-grade bilingual delivery, and a flexible engagement model — without the overhead of a 5,000-person CRO.
Most foreign biotechs entering Japan inherit a familiar problem: the global CROs price for enterprise pharma, the domestic Japanese CROs require local relationships you don't have, and the freelance consultants don't scale. The mid-sized sponsor is left navigating PMDA on instinct.
iCRO exists for that gap. We deliver senior, bilingual regulatory expertise through a flexible engagement model — you get the consultant you need, for the scope you need, without the overhead of a 5,000-person CRO. Our delivery is anchored in Tokyo, supported from Singapore for regional coverage, and scaled through Mumbai for cost-efficient operational work.
Behind iCRO sits Ideal Folks — nine years of bilateral Japan talent operations. That gives us something most boutique consultancies don't have: direct access to the senior regulatory talent pool in Tokyo, and the ability to assemble the right team for your specific filing — not the team that happens to be on the bench.
Japan operates three distinct regulatory pathways for advanced therapies — and the choice of pathway determines your timeline, cost, evidence requirements, and post-marketing obligations. Most foreign sponsors don't realize this until late in their program. We make sure you choose correctly from the start.
The conventional NDA-equivalent pathway for biologic products — monoclonal antibodies, recombinant proteins, vaccines, biosimilars, antibody-drug conjugates, cytokines, and therapeutic enzymes. PMDA scientific consultation, bridging strategy, eCTD submission, and post-marketing surveillance.
Japan's distinctive pathway for cell-based products: CAR-T, TCR therapies, stem cell products, iPSC-derived therapies, tissue-engineered products. Includes the conditional and time-limited approval framework that allows market entry on probable efficacy with post-marketing real-world data collection.
Gene therapy products — AAV, lentiviral vectors, oncolytic viruses, genome editing therapies — face two parallel approval processes: PMDA scientific approval and Cartagena Act biosafety clearance. The most procedurally complex modality in Japan, and the single most common timeline failure for foreign sponsors.
Foreign gene therapy sponsors routinely discover Japan-specific biosafety requirements after their shedding studies are designed. The result: 12–24 month launch delays, repeated studies, and PMDA approval received but product cannot launch. We catch this in the first consultation.
Three tiers of service, organized by depth and modality. Most engagements begin with regulatory strategy or PMDA consultation support, then expand based on program needs. We are transparent about what we deliver directly and what we deliver through our licensed partner network.
End-to-end roadmap from global pipeline to Japan launch. Pathway assessment, bridging strategy, classification, Sakigake & orphan designation, MRCT integration, launch sequencing.
Preparation, attendance, and follow-through across all PMDA consultation types — Initial, CMC, Clinical, Regenerative Medicine, eCTD, Pre-NDA. Briefing packages, question strategy, mock meetings, minutes.
Japan eCTD compilation, XML backbone, hyperlinking, PMDA validation, lifecycle management. CTN, NDA/BLA, partial change applications, re-examination submissions.
CTD Modules 1–5 authoring, clinical and nonclinical summaries, PMDA briefing books, response documents, RMPs — with native-grade Japanese translation managed in-house.
Your designated regulatory communication channel in Japan — PMDA correspondence, scientific advice coordination, submission liaison, importation administrative support. Formal Clinical Trial Caretaker (治験国内管理人) and DMAH coverage structured through our licensed partner network.
Module 3 authoring, Quality Overall Summary, Japan-specific CMC requirements, process validation strategy, analytical comparability, container closure validation, stability strategy.
CTN preparation, IND-equivalent submissions, J-GCP-compliant protocol localization, investigator brochures, ICF localization, safety reporting, DSMB charters.
GVP & GPSP compliance advisory, local QPPV-equivalent (安全管理責任者) consulting, PV system establishment guidance, RMP preparation, signal detection methodology, periodic safety reports.
Japan GMP gap assessments, GCTP compliance for cell & tissue products, QMS harmonization, mock PMDA inspections, site master file preparation, vendor qualification strategy.
Partial change applications, manufacturing change support, new indication submissions, label expansion, post-approval commitments management, biosimilar lifecycle strategy.
Japanese package insert (添付文書) preparation, IFU localization, medication guide preparation, patient labeling compliance, promotional review support.
AAV, lentiviral, CAR-T, TCR, iPSC-derived products, oncolytic viruses, genome editing therapies. Viral vector characterization, RCV testing, biodistribution, shedding studies, integration risk, long-term follow-up strategy.
Conditional and time-limited approval pathways under PMD Act Chapter 9, Cartagena Type 1 Use applications, environmental risk assessment, biodiversity impact assessment, GMO transport compliance, institutional biosafety support.
CDx regulatory strategy, parallel submission planning, drug-device combination product classification, Shonin/Ninsho pathway navigation for the device component.
Our senior consultant network covers the therapeutic areas where foreign sponsor demand for Japan entry is highest and where Japan's regulatory frameworks are most distinctive. Engagements outside these areas are accepted selectively and matched to specialist consultants in our extended network.
Japan's orphan drug designation pathway, ultra-rare indication strategy, conditional approval positioning.
AAV gene therapy for inherited retinal disease, anti-VEGF biologics, ocular drug delivery, age-related macular degeneration.
Autologous and allogeneic CAR-T therapies, ADCs, immuno-oncology biologics, conditional approval for hematologic malignancies.
Diabetes biologics, growth hormone therapies, lysosomal storage disorders, biosimilar strategy in established categories.
AAV gene therapies for SMA, neurodegenerative biologics, blood-brain barrier-targeted therapies, ALS and Huntington's.
Hemophilia gene therapies, sickle cell ex vivo therapies, rare bleeding disorder biologics, thrombotic disorders.
mRNA platforms, autoimmune biologics, novel adjuvant strategy, post-COVID vaccine approval frameworks.
iPSC-derived therapies, mesenchymal stem cell products, tissue-engineered constructs — Japan's flagship category.
Most CROs sell you a team and bill you for it whether they are busy or not. We do the opposite. iCRO is a curated network of senior PMDA-experienced consultants, deployed against your scope, supported by a permanent Tokyo project management layer and offshore delivery capability in Singapore and Mumbai.
We match each engagement to the specific PMDA experience it needs — CMC, clinical, CGT, post-marketing. The senior expert assigned to your file has actually filed your modality before, not just read about it.
One Tokyo-based partner owns your engagement end-to-end. The delivery team scales up or down based on the work, not the org chart. You are never the smallest client in our portfolio.
Every senior consultant operates in Japanese and English. Our Japanese-language work product is native-grade, reviewed by people who write in it daily — not localized from English at the last mile.
Strategy in Tokyo, regional coordination in Singapore, operational scale in Mumbai. One contract, one project lead, three time zones working for you.
The single most common mistake we see: foreign sponsors engaging Japan regulatory support after a global strategy is locked. The cheapest, fastest, lowest-risk path to PMDA approval almost always involves Japan-specific decisions made early — bridging strategy, MRCT design, CMC choices, Cartagena Act planning for gene therapies. Talk to us before those decisions are made, not after.
A working session with a senior iCRO consultant. We review your asset, modality, current status, and Japan-relevant decision points. No deck, no pitch — just a useful conversation.