Mt. Fuji, Shizuoka, Japan

We Develop Your Pharmaceutics, IVDs, MDs and Cosmetics in Japanese and Global Markets.

Practical consulting led by a Pharmacist and Ph.D. in Pharmaceutical Sciences across R&D, Regulatory (PMDA/FDA), CMC, QMS/GMP, and manufacturing — enabling faster, compliant market entry.

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PMDA / FDA
ISO 13485
GMP / GQP / GVP
CMC
IVD

Dr. Shuichi Tanabe

CEO / Pharmacist (Japan) / Doctor of Pharmaceutical Sciences

Leadership experience at Yakult, Astellas, QIAGEN, Galderma, and Estée Lauder.
End-to-end support: R&D → CMC → Regulatory → QA/QMS → Manufacturing.
Global compliance expertise: PMDA/FDA, ISO 13485, audits.

Services

Hands-on support tailored to your product stage, risk profile, and target markets.

Regulatory & Quality (PMDA/FDA)

Regulatory strategy and gap assessment for JP/US/EU
PMDA/FDA meetings, briefing books, deficiency responses
CTD authoring/review and submission management
QMS/GMP/GQP/GVP system build and internal audits
ISO 13485 readiness and supplier audits

CMC & Development

CMC strategy for small/large molecules; control strategy
Analytical validation and stability program design
Tech transfer, scale-up, and process validation
ADME/TK study planning and integration
CTD Module 2/3 authoring and review

IVD & Medical Devices

Approval pathways (Class I–IV) and CDx strategy
Design control and risk management (ISO 14971)
Equipment validation (IQ/OQ/PQ), assay validation
Clinical performance studies and PMS planning
Lab/plant readiness and manufacturing optimization

Cosmetics & Quasi-drugs

PMDL compliance, labeling, and claims review
GMP/QA system setup and supplier qualification
Formula/ingredient due diligence and safety file
OEM/ODM selection and quality agreements

Business Development & Market Entry

Market access and pricing insights for Japan/US/EU
Partnering and licensing support; term sheet review
Investor relations and fundraising narratives
KOL and key hospital engagement planning

Training & SOPs

GxP/QMS in-house training (RA/QA/R&D/Manufacturing)
SOP system design, document control, and audit trails
Leadership coaching and cross-functional alignment

Careers

We are hiring experienced CMC Regulatory Affairs professionals. Fully-remote, flexible hours, competitive hourly rate.

Contact

We typically respond within one business day.

📧 info@drshu.co.jp

📞 +81-90-8861-9309

📍 1-1-7-2 Tonosawa, Shimizu-ku, Shizuoka 424-0912, Japan

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