INITIALIZING...

Accelerating Therapeutic
Innovation.

We bridge the gap between scientific discovery and patient care by guiding and emerging pharmaceutical companies through the clinical development.
Our comprehensive consulting services include strategic, regulatory, scientific, and clinical operation support for clinical development in Japan.

Decades of Integrated Regulatory and Clinical Excellence.

Our experts track record spans the early-stage clinical development phase to the Japan NDA review and approval stage. We have experience with complex therapeutic areas, including cardiovascular and renal diseases, endocrinological and metabolic diseases, neurological diseases, oncology, immunology, and rare diseases, including pediatric indications.

  • 50+PMDA formal consultations (CMC, non-clinical, clinical) including regenerative medicine projects in
    recent 5 years.
  • 20+Clinical trial operations experiences including 10+ ICCC (in country clinical care-taker
    responsibilities)
  • 15 Japan approval experiences

Strategic, Regulatory,
Scientific Leadership.

Our team consists of Ph.D. scientists, and exceptional regulatory experts dedicated to navigating the complexities of innovative medicine development.
Unlock potential in Japan Medicine Development with our top-notch team.
Experience our unmatched expertise, creativity, and collaborative work approach, coupled with exceptional communication and cultural proficiency.
We work as an extension of your own R&D department.

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Partner With Us.

Ready to advance your pipeline?
Contact our Tokyo head-office for a consultation.

info@k2dev-solutions.com

K2 Development Solutions Inc.
Shibuya Scramble Square 39th floor, 2-24-12 Shibuya, Shibuya-ku, Tokyo, 150-0002 Japan


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