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Creating a
Confident
Reliable
Enduring
Healthcare Tomorrow

Mission

To strengthen the link between healthcare and society, raising the quality of medicines and care.

Vision

As specialists in pharmaceutical regulation, we deliver Japan-based consulting globally leading the growth of Japan-quality regulatory support that stands up internationally.

Values

  • Expertise: Strong command of regulatory frameworks and health systems
  • Integrity: Clear, honest, and principled counsel
  • Collaboration: Close cooperation with providers, regulators, and global partners

About Us

Gene And Serve Inc. is a specialized medical writing and regulatory partner dedicated to delivering accurate and timely pharmaceutical information in Japan. We support global pharmaceutical companies with high-quality prescribing information development and revision services, ensuring full compliance with Japanese regulatory requirements. With extensive experience in Regulatory Affairs and global collaboration, we provide documents that are clear, reliable, and fully aligned with PMDA expectations.

Our Services

Prescribing Information Development

Comprehensive creation of Japanese prescribing information for submissions and label changes aligned with PMDA guidance.

Learn about JP PI Requirements →

Prescribing Information Revision

Timely, accurate updates informed by post-marketing safety data, re-examination results, and global evidence.

PMDA Contact

Reliable point of contact for all PMDA inquiries and correspondence.

Documentation Support

Clear meeting decks, briefing documents, and response packages in English and Japanese.

Bilingual Regulatory Writing

Fluent, consistent translations bridging global HQ and Japan affiliates.

Training Materials

Evidence-based materials for Healthcare Providers and patients.

Mikiko Shitara

Mikiko Shitara

Representative Director & CEO

Master of Science in Pharmaceutical Sciences, Tokyo University of Science

With more than twenty years of experience in the pharmaceutical sector, my primary expertise lies in regulatory affairs, e-Labeling, and strategic pharmaceutical initiatives. As the lead for e-Labeling at the Rare Disease Unit within Alexion Pharma GK/AstraZeneca Japan, my mission was closely aligned with the company's commitment to innovative healthcare solutions. I offer a distinctive viewpoint to the team, utilizing my vast experience to promote regulatory excellence and initiatives focused on patient care.

Our Process

1

Kick-off

Set goals, context, and schedule.

2

Drafting

Write precise, compliant documents.

3

Review & Alignment

Consolidate comments from Japan and global teams.

4

Finalization

Release submission-ready documents with version control in place.

Ensuring Business Continuity in a Fluctuating Regulatory Environment

In Regulatory Affairs, workload can fluctuate dramatically depending on regulatory authorities' timelines and requirements. These unexpected surges often place significant pressure on project teams, sometimes making it difficult for members to take their planned paid leave or important personal time off.

Our service provides a reliable solution to this challenge. We offer hands-on expertise to help teams manage the intense demands of regulatory submissions. By stepping in seamlessly, we support the smooth execution of projects, reduce pressure on internal teams, and help maintain a healthy work–life balance across the organization.

In periods when multiple projects overlap or when internal resources become limited due to personal circumstances, our flexible support model enables your team to continue operations confidently and without interruption.

Contact

Address

N&E BLD 6F, 12-4 Ginza 1-chome, Chuo-ku, Tokyo

〒104-0061 Japan