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.
• 1. IND (Investigational New Drug Applications)

  2. NDS/NDA (New Drug Submissions/Applications)

  3. ANDS/ANDA (Abbreviated New Drug Submissions/Applications)