Regulatory Consulting

Halloran understands that the right regulatory strategy and quality system are key functions in meeting and maintaining compliance with government standards, but respects that there is no "one size fits all" approach. Our experts help implement strategies and solutions that meet your unique business requirements while ensuring that scalable quality is built into the process from day one. We will also work closely and collaboratively with you to minimize regulatory risk and eliminate unnecessary bureaucracy.

Halloran's regulatory services include:

• Development and implementation of strategies to quickly progress compounds over regulatory hurdles to key value inflection points
• Performance of gap analyses to ensure that development activities meet global regulatory standards and that product candidates are positioned for efficient development
• Creation or modification of key development documents including Investigational New Drug (IND) and New Drug Application (NDA) project plans, regulatory strategy documents and global development plans
• Compilation and submission of regulatory documents
• Interim regulatory and quality management services

For more information, contact us at info@hallorancg.com.