Regulatory Support & Dossier Compilation

We at Aizant offer expert regulatory support to confirm that every submission aligns with the requirements of global regulatory agencies, including the FDA, EMA, and other leading authorities. Our regulatory affairs team works diligently to provide a seamless experience, guiding through the complexities of regulatory filings and adhering to requirements at every step.

Regulatory Services

Dossier Compilation and Preparation

Our team rigorously compiles, organizes, and prepares regulatory dossiers for submission to health authorities. Whether it’s for new drug applications (NDA), investigational new drug (IND) applications, or 505(b)(2) filings, we confirm that all necessary documentation is thorough and meets the requirements of regulatory bodies.

Regulatory Filing & Submissions

We assist in the preparation and submission of regulatory filings to authorities such as the FDA, EMA, TGA, and other global agencies. Our team guarantees that the filing process is smooth and that the submission is complete, accurate, and in compliance with current regulations.

Regulatory Strategy
Development

We understand that each product and market has its own unique regulatory requirements. We provide customized regulatory strategies that are aligned with product’s development stage and target markets, securing the most efficient path to approval.

Ongoing Regulatory
Compliance

After product approval, we continue to support ongoing regulatory compliance, including amendments, renewals, post-market surveillance, and audits. We make sure that product stays compliant with local and international standards throughout its lifecycle.

Global Regulatory Affairs

Aizant’s expertise spans multiple regions, helping companies navigate the regulatory landscape for various markets. From initial regulatory submissions to meeting country-specific guidelines, we assist in aligning the product with the expectations of regulatory authorities worldwide.

Partner with us to navigate the complexities of global pharmaceutical regulations
and achieve a seamless path to market success.