Regulatory Advice

QCTR have the depth of experience to provide the expert regulatory advice and practical assistance you need for your clinical trial programme, to give the best chance of success. Our regulatory services include:

• Clinical Trial Authorisation (CTA) applications
• Maintenance of CTAs
• Preparation of orphan drug designation applications for the FDA and EMA
• Preparation of scientific advice packages for EMA
• Preparation of Special Protocol Assessment packages for FDA
• Review of pre-clinical and clinical development programmes and gap analyses
• Review of documentation and scientific due diligence
• Advising on regulatory strategies for both FDA and EMA for the particular disease under investigation and type of drug
• Scientific literature review and searches
• Design of an efficient and effective development program
• Project planning and management to ensure a smooth path to regulatory approval