ClinTec can provide full regulatory support tailored to your exact requirements. Our regulatory experts are able to provide consultancy for interventional, observational and medical device studies. In addition, ClinTec provides expert advice for clinical development in specific therapeutic areas and orphan indications. ClinTec's global footprint and network of experts, including those in the emerging markets, ensures that all regulatory activities are of the highest quality and compliant with the regulations and cultural nuances in these specific regions. The regulatory services provided by ClinTec include, but are not limited to: 


Pre-submission Document Review 

• Protocols
• IBs
• IMPDs
• ICFs
• IMP labels
• CTDs


Clinical Trial Regulatory Support 

• Submission requirement consultation
• Preparation and management of clinical trial applications to Regulatory Authorities
• Substantial amendments
• End of trial and study outcome reporting


Regulatory Consultancy

• Study design consultation
• Clinical development planning
• Scientific advice assistance - preparation for regulatory authority meetings
• Orphan drug applications
• Advanced therapy medicinal product consultation
• Medical device development