Infinitus has a comprehensive understanding of local regulatory requirements for clinical studies. Our pharmaceutical regulatory consultant services offer the best solutions to meet all kinds of challenges for pharmaceutical, biotechnology, device and diagnostics companies. We collect, maintain and distribute essential documents to both the sponsor and the regulatory authority, as required by sponsor, regulation and trial protocols. Regulatory applications are made in parallel with Ethics Committee submissions, and trials are carried out to national guidelines laid out by the International Conference on Harmonisation of Good Clinical Practice (ICH-GCP).

 Our core pharmaceutical regulatory affairs expertise is in the following areas

• Clinical Trial Approval
• Clinical Trial Protocol Amendment Approval
• Approval for Medical Device Studies
• Safety Reports Updating
• New Drug Approval
• Import Licenses and permits for commercial and experimental use
• Export permission/ permit for biological samples

 Our major strengths are:

• Regulatory pathway selection based upon time management
• Accuracy and precision in responding to exact pharmaceutical regulatory requirements
• Creation of state-of-the-art regulatory dossiers
• Excellent professional interactions with regulatory bodies of India
• In-depth understanding of regulatory requirements for biotechnology products and drug related laws