At Tactus Lifesciences, Our Regulatory Due Diligence & Gap Analysis service ensures that your journey from product development to market approval is smooth and compliant every step of the way.

Why Regulatory Due Diligence Matters:

There is paramount importance of regulatory due diligence for Marketing Authorization Holders (MAHs). Whether you're embarking on a new venture or managing an existing product line, staying in control of regulatory activities is essential.

Our service offers meticulous audits to ensure that all aspects of your medicinal product meet regulatory standards, even those conducted by third parties. We understand that regulatory compliance is not just about avoiding penalties it's about safeguarding your reputation and ensuring uninterrupted product distribution.

Regulatory Compliance Gap Analysis

We conduct detailed assessments to identify gaps in regulatory submissions and provide strategic recommendations to mitigate risks and ensure compliance.

Marketing Authorization Dossiers

Whether it's a new data set or an existing MA, we conduct comprehensive reviews to assess completeness, compliance with guidelines, and ongoing regulatory issues.

Clinical Trial Applications

Our team meticulously reviews CTA submissions to ensure a 'right first time' application, minimizing validation errors and accelerating the approval process.

Our Comprehensive Approach

Our approach covers a wide spectrum of regulatory aspects, leaving no stone unturned in ensuring compliance and identifying potential gaps. From assessing submission packages for clinical trials to reviewing marketing authorization dossiers, we provide thorough analysis and recommendations for improvement. Our expertise spans various product types, including biotech, small molecules, generics, and orphan drugs, ensuring tailored solutions for diverse needs.