Medifodil- Smart Pharma Solutions

Regulatory Intelligence & Market Entry Strategy

Country-specific regulatory landscape assessments. Customized market entry strategies based on local compliance requirements. Regulatory gap analysis for global expansion.

Audit & Inspection Readiness

Mock inspections and internal audits to identify compliance gaps. FDA, EMA, CDSCO, and MHRA regulatory inspection preparation. Development of Corrective and Preventive Action (CAPA) plans.

End-to-End Compliance Workflow Development

Digital transformation of regulatory workflows. Implementation of AI-driven document management and tracking systems. Compliance training programs for regulatory teams.

Regulatory Dossier Preparation & Submissions

Continuous monitoring of evolving global regulations. Ensuring alignment between regulatory compliance and pharmacovigilance activities. Lifecycle regulatory strategy for drug approvals and renewals.

Post-Market Compliance & Pharmacovigilance Alignment

Continuous monitoring of evolving global regulations. Ensuring alignment between regulatory compliance and pharmacovigilance activities. Lifecycle regulatory strategy for drug approvals and renewals.

Let’s Build a Smarter Pharma Future Together

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