Simaron Biopharma Research

Contract Research Soultions

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Contract Assay Services, a division of Simaron Biopharma Research, is a dedicated contract research organization (CRO) specializing in assay services that utilize both in vitro and in vivo primary stem cell assays. By leveraging advanced stem cell technologies, media, and reagents, our expert scientists deliver high-quality standardized and customized assay solutions. We offer a diverse portfolio of characterized assays that utilize pre-qualified primary stem cells, ensuring reliability and accuracy. Additionally, our in-house specialists are available to discuss and address your unique research requirements, guaranteeing tailored approaches that meet your specific needs. Whether you seek to enhance existing methodologies or develop new assays, Contract Assay Services is committed to advancing your research with excellence and innovation.

Cell and Stem Cell Therapy

Are you in need of assistance with your diagnostic assay development or a tailored solution for your sample preparation process? Simaron Biopharma Research offers a comprehensive range of diagnostic partnerships and OEM solutions, allowing us to collaborate with you to optimize your workflows and create effective sample preparation solutions customized to your requirements. Our team of qualified experts is dedicated to delivering the best possible outcomes for your project, whether you seek to register an existing product as an in vitro diagnostic (IVD) device or require support through an original equipment manufacturer (OEM) agreement. With our experienced technical and regulatory guidance, we are here to help you achieve success in your diagnostic endeavors.

Product Development & Regulatory Services

We provide end-to-end support for biopharmaceutical product development with a strong focus on regulatory strategy and compliance. Our services are designed to streamline your path from discovery to market, ensuring alignment with global regulatory requirements.

Our Expertise Includes:

• Regulatory Strategy & Submissions
  IND, CTA, NDA, BLA, 505(b)(2), orphan drug applications, and more.

• Preclinical & Clinical Development
  Study design, CRO management, and regulatory-aligned protocol development.

• CMC Consulting
  Drug substance/product development, quality systems, and submission-ready documentation.

• Agency Interactions
  Preparation for FDA/EMA meetings and expert response to regulatory queries.

• Post-Approval Support
  Lifecycle management, variations, pharmacovigilance, and compliance.