At Anilocus, we specialize in providing comprehensive preclinical regenerative medicine contract research services. As a growing regenerative medicine CRO we are committed to conducting nonclinical studies to assess the safety and efficacy of cell-based and gene-based regenerative medicine drugs. We aim to support the development of innovative regenerative therapies.

We want to collaborate with your team and provide your regenerative medicine contract research services. Through our rigorous scientific approach and adherence to FDA guidelines and Regulation of Regenerative Medicine Products, we provide accurate and detailed assessments of the safety and efficacy of your products. We are here to support your journey in bringing innovative regenerative therapies to patients in need.

Our services include the following:

Regenerative Medicine Study Design and Consultation

  • Collaborative consultation to understand your specific research goals and requirements.
  • Expert guidance in designing nonclinical studies for regenerative medicine products.
  • Tailored study protocols to meet regulatory and scientific standards.

In Vivo Efficacy Studies for Regenerative Medicine Therapies

  • Conducting comprehensive in vivo studies using animal models to evaluate the efficacy of regenerative medicine drugs.
  • Assessment of treatment endpoints and research outcomes, such as tissue regeneration, functional improvements, and biological responses.
  • Analysis of data to provide valuable insights into the therapeutic potential of your product.

Safety and Toxicology Studies in Regenerative Medicine

  • Detailed safety pharmacology assessments to identify potential adverse effects and determine dose-response relationships of cell-based and gene-based therapies with restorative and regenerative properties.
  • Evaluation of systemic toxicity, local tolerability, and target organ toxicities.
  • Comprehensive analysis of histopathological findings and safety biomarkers.

Pharmacokinetic and Pharmacodynamic (PK/PD) Studies

  • Accurate determination of drug absorption, distribution, metabolism, and excretion (ADME).
  • Assessment of pharmacological effects and dose-response relationships.
  • Formulation optimization and dosage recommendations.

Regulatory Support for Regenerative Medicine Nonclinical Studies

  • Assistance in preparing and submitting regulatory documents, including Investigational New Drug (IND) applications.
  • Compliance with GLP principles to ensure reliable and transparent reporting of experimental work.
  • Expert advice on FDA regulations and guidelines for regenerative medicine products.

Contact us today to discuss your research needs and discover how Anilocus can help accelerate your drug development.

References

  1. Beierle J, Algorri M, Cortés M, et al. Structured content and data management-enhancing acceleration in drug development through efficiency in data exchange. AAPS Open. 2023;9(1):11. doi:10.1186/s41120-023-00077-6.
  2. The Alliance for Regenerative Medicine. Available Products [Internet]. (https://alliancerm.org/available-products/).
  3. Advanced Therapy Medicinal Products: Overview. Available online at: https://www.ema.europa.eu/en/human-regulatory/overview/advanced-therapy-medicinal-products-overview (accessed July 15, 2019).
  4. Brindley DA, Davie NL, Culme-Seymour EJ, Mason C, Smith DW, Rowley JA. Peak serum: implications of serum supply for cell therapy manufacturing. Regen Med. 2012;7(1):7-13. doi:10.2217/rme.11.112.
  5. U.S. Department of Health and Human Services. Food and Drug Administration. Expedited programs for regenerative medicine therapies for serious conditions. Guidance for Industry, February 2019.