Regulatory Services

Expert guidance to navigate the complex world of regulatory approvals.

 Dossier Drafting & Gap Analysis – Ensuring complete and compliant submissions.

 Local Agent Support – Facilitating smooth entry into new markets.

 Module Compilation & Deficiency Response – Addressing regulatory requirements with accuracy.

 Regulatory Document Preparation & eCTD Submissions – Simplifying submission processes for compliance success.

 Dossier Drafting & Gap Analysis

 Local Agent Support

 Module Compilation & Deficiency Response

 Regulatory Document Preparation & eCTD Submissions (IND, NDS/NDA, ANDS/ANDA)