About Us

Why Choose NYK BioSolutions?

At NYK BioSolutions, we stand as a forward-thinking organization led by experienced technocrats and business development professionals. Our team, composed of seasoned professionals and associated partners, brings extensive expertise in the pharmaceutical and medical device industries. Together, we specialize in facilitating market readiness for drugs and medical devices through comprehensive testing and regulatory compliance.

Our team and associated partners possess unparalleled experience in preclinical testing, toxicology, regulatory compliance, and business development. With a commitment to delivering tailored solutions, we ensure your products achieve market readiness while adhering to stringent international standards.

What We Do

  1. Biocompatibility Studies
    • We conduct biocompatibility studies in strict compliance with ISO standards, ensuring high-quality and reliable results.
  2. Regulatory Expertise
    • Reports submitted by our team members are well accepted by various national and international regulatory bodies.
  3. Drug Discovery & Regulatory Compliance
    • We specialize in:
      • Preclinical research
      • Toxicological testing
      • Clinical research support
      • Strategic patent grants for IND application submission to DCGI
      • Facilitating CDSCO regulatory approvals to enable smooth transitions to clinical trials
  4. Medical Device Testing Support
    • We provide:
      • Chemical characterization
      • Toxicological risk assessments
      • Comprehensive testing in line with international regulatory standards
  5. Pharmaceutical Testing & Lab Setup
    • We assist in establishing advanced pharmaceutical testing laboratories, offering:
      • Operations management
      • Instrumentation support
      • Deployment of specialized human resources
      • Business development expertise

Track Record of NYK BioSolutions Team Members

  • We partner with over 25 manufacturers globally, providing tailored solutions for their biocompatibility and testing requirements.
  • We support clinical trials for regulatory approvals, ensuring seamless execution and strict adherence to compliance standards.
  • We assist domestic drug manufacturers with contract manufacturing and marketing strategies.