FDA
At Aquila Solutions, we recognize the critical role of the FDA (U.S. Food and Drug Administration) in ensuring the safety, efficacy, and security of drugs and biologics in the United States. Navigating the intricate regulatory landscape managed by the FDA can be daunting for small to medium pharmaceutical and biologic companies. Our expertise equips you to successfully meet FDA regulations and advance your product from development to market.
eCTD Regulatory Publishing
Our eCTD Regulatory Publishing services simplify the submission process to the FDA by ensuring that all regulatory documents are compiled, formatted, and submitted in compliance with eCTD standards. With a proven track record of same-day and next-day submissions, we ensure your documents are error-free, significantly accelerating your time to market.
SPL Authoring
Structured Product Labeling (SPL) is essential for effective communication with healthcare providers and patients. Our SPL Authoring service guarantees that your product labeling aligns with FDA guidelines. Our experts ensure your labels are accurate, compliant, and tailored to meet regional requirements, enhancing clarity and safety for end-users.
Regulatory Consulting
Understanding the FDA’s evolving requirements is crucial for maintaining compliance. Our Regulatory Consulting services offer strategic insights and guidance throughout the product development lifecycle. From initial planning to post-marketing requirements, our experienced team navigates complexities, helping you streamline processes and minimize regulatory risks.
eCTD Viewer
Communication with the FDA is elevated with our Altair eCTD Viewer. This user-friendly software simplifies document management, enabling efficient reviews and annotations of electronic submissions. With advanced search and security features, our eCTD Viewer enhances collaboration with regulatory authorities, expediting the review process and ensuring compliance.
Trust Aquila Solutions for Your Regulatory Requirement Needs
Aquila Solutions stands ready to be your trusted partner in navigating the FDA regulatory landscape. Our comprehensive services are tailored to meet the unique needs of your business, helping you achieve compliance and expedite your product's journey to market. Contact us today to learn more about how we can assist you in your FDA submissions and enhance your regulatory success.