Drug Development Strategies
Choosing the right development strategy is essential for achieving commercial success. As biotech companies invest in advanced therapies and global trials, there is growing emphasis on regulatory planning, including the design of clinical protocols, nonclinical testing, and manufacturing processes. Greenline Clinical Research offers top-tier regulatory services to accelerate drug development in the complex and ever-changing research landscape.

Core Regulatory Services

• Assessment of regulatory gaps and strategy development
• Design and review of nonclinical toxicology studies
• Preparation of Investigator Brochures (IBs)
• Global regulatory submissions, including IND, DMF, NDA, BLA, and combination products
• • Preparation of meeting materials and briefing packages for Type A, B, and C meetings, and scientific advice
  • Support for fast track and orphan drug designations
  • USA agent services
  • Assistance with Institutional Biosafety Committee and GMO medicine applications

  Core Medical Services

  • Medical writing
  • Clinical trial design
  • Medical monitoring
  • Pharmacovigilance

  From the initial stages through development and approval, our team supports you throughout every phase of the process.