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:

OUR REGULATORY CONSULTING SERVICES INCLUDE

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.

Why Choose Turacoz?

  • Regulatory Expertise
    Our expert writers brings deep knowledge of global regulatory frameworks, including ICH, FDA, EMA, and other international guidelines, ensuring your submissions meet the highest standards.
  • Full-Spectrum Support
    From the study protocols to safety reports, we offers seamless support across all document types such as CSRs, CTDs, RMPs, and more, delivering clarity, accuracy, and compliance at every stage of development.
  • Reliable Quality, Zero Compromise
    Every document undergoes rigorous internal review, ensuring accuracy, consistency, and alignment with evolving regulatory requirements.
  • Fast and Focused Delivery
    With strong project management and skilled writers, we ensure submission-ready documents are delivered on time without ever compromising quality or compliance.
    At Turacoz, we are committed to delivering regulatory documentation that drives smooth, efficient, and successful approvals. With our expertise and collaborative approach, your products can reach markets faster and make a meaningful impact on patient lives.

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