CMC: Regulatory Affairs

Overview

Rondaxe has a team of highly experienced industry experts available to provide CMC (Chemistry, Manufacturing & Controls) regulatory affairs consulting services. We can assist with all aspects of manufacturing & supply chain issues or regulatory strategy planning and the preparation of regulatory documents and applications.

Regulatory Strategy

• Advice from experienced regulatory affairs experts on manufacturing, analytical, and supply
  chain issues including starting material selection and change control
• Identify and document the supply chain
• Assembly of CMC sections of INDs and NDAs
• Preparation of DMFs

Benefits

• Access to top level industry experts
• Efficient resolution to regulatory issues
• Regulatory Strategy for starting material designation
• Regulatory Strategy for organization
• Streamline regulatory filings
• Preparation of IND, DMF, NDA documents for regulatory filing