Contract Research Organization (CRO)

Our CRO services are designed to accelerate drug discovery and development through flexible and efficient models such as Fee-for-Service (FFS) and Full-Time Equivalent (FTE) partnerships. We customize our services to meet the unique requirements of your research and development goals.

Key Offerings

Preclinical Studies

  1. Comprehensive toxicology assessments to ensure safety profiles before human trials.
  2. In vivo and in vitro efficacy studies to establish proof of concept.
  3. Pharmacokinetics (PK) and pharmacodynamics (PD) studies to evaluate absorption, distribution, metabolism, and excretion (ADME) properties.
  4. GLP-compliant studies designed to meet global regulatory standards.

Clinical Trials Management

  1. End-to-end support for clinical trials across Phases I-IV, ensuring timely and effective execution.
  2. Expertise in designing trial protocols that meet regulatory and ethical standards.
  3. Patient recruitment and site management services tailored for diverse populations.
  4. Real-time data monitoring and analysis to ensure the integrity of trial results.
  5. Seamless collaboration with global regulatory agencies to expedite approvals.

Regulatory Support

  1. Comprehensive global dossier preparation tailored to individual market requirements.
  2. Assistance with regulatory submissions for new drug applications (NDAs), investigational new drug applications (INDs), and more.
  3. Expert guidance to navigate the complexities of regulatory compliance in multiple regions.
  4. Dedicated support for labeling, packaging, and product registration.

Pharmacovigilance

  1. 24/7 monitoring and reporting systems to always ensure patient safety.
  2. Adverse event management and signal detection to minimize risks.
  3. Preparation and submission of periodic safety update reports (PSURs).
  4. Proactive risk management plans (RMPs) to meet post-marketing surveillance requirements.

At Terazed Lifesciences, we are dedicated to delivering comprehensive services that empower our clients to achieve their goals. Whether it's through cutting-edge research, efficient manufacturing, or regulatory expertise, we strive to be a trusted partner in advancing healthcare innovations worldwide.

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