Regulatory Consulting Services

Turacoz provides expert regulatory writing services that streamline the documentation process in the pharmaceutical industry, from preclinical to clinical research. We specialize in creating concise manuals, drug information, and educational materials. We are proficient in documenting trial processes, safety protocols, and results. Our services ensure efficient, accurate, and clear clinical documentation for regulatory submissions. We help you prepare:

Effective Pre-IND Meeting Questions

Pre-Investigational New Drug (Pre-IND) Meetings are crucial for sponsors to present their drug development plans to the FDA. We assist in planning your agenda to ensure alignment with regulatory expectations and clear end objectives. These meetings help minimize the risk of clinical holds and reduce development costs.

Scientific Advice and Briefing Packages

We prepare you for Scientific Advice meetings, crafting necessary briefing packages to ensure productive discussions with regulatory bodies. Our support clarifies your development strategy, refines study design, and aligns your approach with regulatory expectations, smoothing the path for successful drug development, and reducing the likelihood of costly delays.

Guiding MAAs and Follow-up Submissions

We streamline the preparation and filing of Marketing Authorization Applications (MAAs) and follow-ups, ensuring rapid approval and long-term market success.

Post-Approval Strategy and Maintenance

We provide strategic planning for post-approval development and product maintenance, focusing on lifecycle management, market expansion, and compliance to ensure your product's long-term success.

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