CTD/ACTD Dossier Management, Gap Analysis, and Market Access

A well-structured regulatory dossier is vital for swift market clearance. Makromed offers complete lifecycle management for regulatory dossiers, performing rigorous gap analyses and providing strategic market entry support to navigate complex approval ecosystems seamlessly.

Regulatory Advisory Services:

• CTD & ACTD Dossier Preparation: Compilation and technical writing of Modules 1 through 5 in full alignment with ICH guidelines.
• Regulatory Gap Analysis: Evaluating existing technical dossiers to identify compliance gaps before official submission.
• Lifecycle Maintenance: Managing post-approval changes, variations (Type IA, IB, II), and license renewals.
• Distributor Search & Market Entry: Identifying and negotiating with high-performing regional distribution partners.

Accelerating product launches through precise documentation and strategic distributor networking.