MakroCare had guided and executed hundreds of successful submissions to the FDA, the EMEA and other national regulatory authorities.

• Technical writing expertise, from highly comprehensive scientific reports to fundamental documentation for premarket and post market needs
• Preparation of chemistry, manufacturing, and controls (CMC) documentation for drug substances and finished formulations
• To Prepare, Compile, & Submit DMFs & Dossiers (Investigational Medical Product Dossier (IMPD) / Investigational new drug (IND) applications, NDAs / MAAs, etc
• Preparation and Submission of Annual Reports, Variation Applications, Renewal Application, Amendments and Supplements
• Response to queries from Regulatory Authorities
• Preparation Periodic Safety Update Reports
• Preparation of RMP & REMS plans
• eCTD submission & Life Cycle Management