POINTERRO

Providing regulatory operation services to our clients for development of investigational new drugs, biologics, biotechnology products (e.g. drug delivery technology), and combination products.

About

Pointerro specializes in delivering comprehensive regulatory operation services to streamline your regulatory submissions and processes.

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Services to allow you to do what you do best

As your dedicated consultant, we take the burden of formatting tasks off your shoulders, allowing you to concentrate on your core expertise—advancing the science of drug development. Our seamless integration into your workflow ensures that the intricate details of document preparation are impeccably managed. This enables you to allocate more time and resources to groundbreaking research, innovative solutions, and critical discoveries that drive the progress of your projects.

Seamless Integration

As your strategic consulting partner, we seamlessly integrate into your company. Our approach ensures minimal disruption while maximizing impact, leveraging our expertise to align with your vision and goals. By becoming an extension of your team, we provide tailored solutions, actionable insights, and unparalleled support, driving your business forward.

Transparent Communication

Clear and transparent communication is the cornerstone of our services. We believe in keeping you informed every step of the way, providing detailed and regular updates to ensure you have complete visibility into our activities and progress. Our open communication channels foster trust and collaboration, allowing us to address any concerns promptly and make informed decisions together. By partnering with us, you can expect an unwavering commitment to transparency.

Our Services

Coordinating the preparation of all necessary documents for regulatory submissions. This includes eCTD compilation, submission tracking, and ensuring timely responses to regulatory authorities.
Our specialized service ensures your documents are meticulously formatted to meet relevant FDA and International standards.
Our Document Life Cycle Management service ensures that your regulatory and compliance documents are meticulously managed throughout their entire lifecycle.
Visit our services page for a full listing of the services Pointerro provides.