PreClinical

The preclinical phase is critical for identifying potential issues early and
ensuring that your product is on solid ground before human trials.

Our experienced team is dedicated to guiding you through this phase
with precision and care, setting the foundation for successful
clinical development.
 

Quality Assurance and Regulatory Compliance

Investigational New Drug (IND) Application

Regulatory Strategy & Submissions

Vendor Selection & Qualification

Project & Risk Management

Technology Transfer

Gap Assessment and Remediation

Quality Management Systems (QMS)

Funding and Investment Strategies

Research and Development (R&D)

Biostatistics and Data Analysis

Lab Operations and Efficiency

Medical Writing

CDMO Vendor Selection Qualification & Oversight

CRO Selection & Qualification

CTO Selection & Qualification

Data Integrity and Software Implementation

Investigational Device Exemption (IDE) Application