Regulatory affairs is an integral and crucial part of MedHimalayas Clinical Research management, ensuring compliance with all relevant regulatory requirements in all stages of every project. Our Regulatory Affairs experts possess extensive knowledge of the regulatory environment and the changing requirements in many countries and regions. They work meticulously in expediting the processes without compromising quality.
     

• Pre-clinical and clinical program evaluation
• ICH-GCP compliance review
• Regulatory strategy development
• Regulatory submissions
• IRB audits and On-site investigator audits
• FDA meetings and presentations