Regulatory Affairs

ClinChoice’s regulatory team offers comprehensive support across various stages of clinical development and regulatory processes.

• Strategic regulatory consulting services
• Regulatory gap analysis, review, and remediation
• Drug and biological development processes
• Regulatory positions for new therapies
• Requests for scientific advice from regulatory bodies
• Approval strategies for regulatory compliance
• Independent due diligence and scientific regulatory reviews
• Regulatory approval processes for orphan drug designations
• Consultation for small molecules, biological drugs, and gene/cell therapy products
• Support with institutional review board or ethics committee documentation
• Regulatory advice for import/export permits and labeling
• Regulatory submission strategies

In the US, our regulatory specialists collaborate with clients to streamline product entry, ensuring compliance with regulations for all FDA regulated products including drugs and biologics with experience supporting the successful development of your NDA or BLA. ClinChoice handles investigational applications, emphasizing compliance with the eCTD format. In Europe, our regulatory experts work closely with various National Competent Authorities to support our Clients with timely and strategic advice to streamline their product development and lifecycle maintenance.

ClinChoice diligently detects and monitors changes, keeping a vigilant eye on regulatory developments. This proactive approach provides clients with timely communication, keeping them abreast of the latest regulatory updates. The team’s effectiveness is amplified by a comprehensive regulatory database, ensuring information is current and easily accessible. We provide expert guidance and advice in the following areas:

• Global Regulatory Strategy Development
• Support for Health Authority Meetings
• Research and commercial IND maintenance
• ANDA, NDA, and BLA submission
• MAA and IMPD submission
• Response to Health Authority Questions
• Global Market Expansion Support

ClinChoice delivers extensive assistance for clinical projects through its Clinical Studies Submissions Database (CSSD), which encompasses study requirements and procedures for medicinal products. Our regulatory intelligence professionals guide your compliance with regional and local requirements by accessing, summarizing, and assessing global regulatory intelligence. Additionally, we consult on country-specific legislation, establish liaisons with authorities and committees, and tailor regulatory training to ensure a holistic approach to regulatory compliance.