Welcome to AO Regulatory Consulting

Our Expertise

AO Regulatory Consulting provides end-to-end Regulatory Affairs solutions from a background of drug development that spans analytical development, clinical manufacturing, quality assurance and regulatory affairs. Let us translate health authority expectations and inner workings for you, and let us be the bridge that explains your product/indication to the health authorities.

AO Regulatory Consulting will ensure you navigate the regulatory landscape with ease.

Why Partner with Our Consulting Firm?

At AO Regulatory Consulting, we specialize in providing top-notch guidance to navigate the complexities of regulatory frameworks. Our experts are committed to delivering tailored solutions that meet the unique demands of each client.

Whether you need expert regulatory affairs strategy to develop the optimal pathway to drug approval, need an experienced regulatory or medical writer or just need assistance with eCTD regulatory submissions, our comprehensive services are designed to support your business objectives.

Partnering with us means leveraging industry expertise to achieve success in your regulatory endeavors. Contact us today to learn how we can assist you.

Regulatory Affairs Strategy

Obtain expert regulatory affairs strategy assistance to develop a roadmap and maximize available health authority benefits, timing, and feedback/interactions.

Medical Writing

Ensure your clinical trial documents present the relevant information accurately, and in a clear format that is easy to understand.

Regulatory Writing

Ensure your regulatory documents are compiled as required by the regulatory guidance and detailed to ensure a positive outcome with health authorities.

Regulatory Information Management (RIM)

Collect, organize and archive documents related to your regulatory submissions and health authority correspondence for quick access by all key team members.

Regulatory Intelligence

Monitor and analyze regulatory intelligence to ensure earlier strategic regulatory actions with the potential to reduce product development timeline.

eCTD Submission Management

Leave electronic common technical document (eCTD) filing in the standard submission format for FDA regulatory application submissions to us.