At Pointerro, LLC, we specialize in providing comprehensive regulatory operations and submission management services to the pharmaceutical, biologics, and biotechnology (e.g. drug delivery technology) industries. Our mission is to streamline the regulatory operations process, ensuring that your products reach the clinic efficiently and compliantly.

We offer end-to-end regulatory operations support, from the publishing and submission of regulatory documents to the ongoing IND maintenance submissions. Our team of experts brings extensive experience and in-depth knowledge of United States Food and Drug Administration regulatory operations requirements, enabling us to navigate the complexities of the regulatory submission landscape with precision and confidence.

Our commitment to excellence is reflected in our proactive approach to regulatory operations, meticulous attention to detail, and dedication to delivering timely and accurate submissions. We leverage industry best practices to optimize the submission process, reduce risk, and enhance regulatory compliance.

Your regulatory operation challenges are our priority, and we are here to ensure your submissions meet the highest standards!