Our expert eCTD (electronic Common Technical Document) strategy development service is designed to streamline your regulatory submission process and ensure compliance with US FDA standards. We provide a comprehensive approach that includes, developing customized strategies, offering training and support, managing submissions, and keeping you informed of regulatory changes. By partnering with us, you can reduce compliance risks, and focus on your core competencies while we handle the complexities of eCTD submissions.

Coordinating the preparation of all necessary documents for regulatory submissions. This includes eCTD compilation, submission tracking, and ensuring timely responses to regulatory authorities.

In today's complex landscape, regulatory operation project management is more than just document preparation; it's about strategic oversight and seamless execution. Our team of seasoned experts ensures your projects not only meet all regulatory submission requirements but excel within them. We specialize in guiding businesses through the maze of document standards.

Our specialized service ensures your documents are meticulously formatted to meet relevant FDA and International standards. We adhere to the FDA's stringent guidelines, structuring documents with standardized templates, precise headings, and accurate data presentation. This includes correct citation of references, clear labeling of figures and tables, and compliance with specific font and margin requirements. By leveraging our expertise, you can streamline the review process and ensuring your documents meet the highest regulatory standards.

Our Document Life Cycle Management service ensures that your regulatory and compliance documents are meticulously managed throughout their entire lifecycle. From creation to archiving, we provide a simple solution with attention to version control. Our expertise ensures that your documents remain compliant with regulatory standards and are readily accessible when needed.

Our eCTD templates provide a streamlined and compliant foundation for your regulatory submissions. Designed to meet FDA standards, these templates ensure consistency, accuracy, and efficiency in your documentation process. By using our pre-structured templates, you can save time and reduce errors, facilitating a smoother and faster path to regulatory submissions.

Our Regulatory Writing service delivers precise and comprehensive documentation to meet the stringent requirements of regulatory authorities for your non-technical content.

On the Medical Writing side, we have partnered with an experienced Medical Writer who specializes in creating well-structured, clear, and compliant documents, including investigator brochures and other regulatory submissions documents. We ensure that each document is meticulously crafted to align with regulatory guidelines and scientific standards.

By leveraging our expertise in regulatory and medical writing, you can enhance the quality of your submissions and facilitate smoother review processes. Trust us to handle your regulatory writing needs with accuracy, professionalism, and efficiency.