Regulatory planning,CMC and bioanalytical issues,Submission assembly

Regulatory Services

Our regulatory submission group assists with all aspects of documentation preparation to support your product's application with pertinent regulatory authorities.

 Our regulatory services include:
  • Regulatory planning
  • Review and counsel on clinical, CMC and bioanalytical issues
  • Submission assembly
  • Planning for and representation at meetings with regulatory authorities

Primary Product Focus
ECI focuses on the 505(b)(2) pathway to gain new drug approvals for unapproved products that are currently on the market as well as those that have been removed from the market. ECI also develops products that are only available through compounding pharmacies.