US and International Regulatory Affairs Services

ARIANNE can provide regulatory assistance for all types of products (small and large molecules, biologics and devices). We provide support for all phases of product development for the FDA and international regulatory agencies.

Regulatory Support Services:

• Regulatory strategic planning
• Liaise with regulatory agencies (e.g., FDA, Canadian, EU and Non EU, Asian agencies)
• Global Sponsor Representation
• Document preparation and submission for clinical studies (INDs, IND Amendments, CTAs)
• Investigational medicinal products dossier (IMPDs), NDAs and BLAs preparation and submissions
• Pre-market Submissions, IDE/510(k)/PMA
• Electronic Submissions
• Preparation and submission of orphan Drug Designation Applications
• Submission and review of IRB approvals for clinical studies
• Preparation and review of investigator’s brochure and updates
• Safety report writing, safety monitoring and SAE reports
• Preparation of annual regulatory reports
• Regulatory Operations; Procedural Review and Audits

Safety Report Writing, Safety Monitoring and the right data analysis is critical for study success. ARIANNE biostatisticians are committed to your success starting with a well-thought and carefully designed analysis plan all the way through to the analysis of study data.

Analysis Plans

Concise, accurate reporting of study results begins with development of clear protocols and accurate, user-friendly case report forms. Our statisticians interact with sponsor scientists to develop a comprehensive statistical analysis plan, including:

• Overview of study objectives
• Description of study population
• Sample size rationale and statistical power
• Methodology for summary and analysis of demographic, baseline, efficacy and safety data
• Description of statistical methodology
• Shells of all planned tables, listings and graphs