R. P. Chiacchierini & Associates, with support from affiliated consultants, provides a broad range of regulatory and clinical consulting services to companies who are involved with or manufacture biologic products.

These services include:

• Strategic product development and regulatory planning
• Protocol development and implementation
• Assistance in Regulatory submissions [IND, ELA/PLA, BLA, IDE, PMA, and 510(k)]
• Strategy development and implementation
• Document and submission preparation
• FDA meeting coordination, preparation and assistance