Regulatory Writing

Regulatory Documents That Propel Your Science Forward

At QuantiNova, we transform complex scientific data into precise, compliant, and submission-ready documents that bridge the gap between your innovation and global market approval. With over two decades of regulatory writing expertise, we deliver clarity, accuracy, and speed — helping you achieve faster approvals with confidence.

The Challenges of Regulatory Documentation

In today’s fast-paced life sciences landscape, even the most groundbreaking research can face delays or rejection if documentation is incomplete, non-compliant, or poorly structured.
Pharmaceutical, biotech, and healthcare companies often struggle with:

Interpreting evolving global regulatory guidelines.
Producing scientifically sound yet regulator-friendly documents.
Meeting tight submission deadlines without compromising quality.

These challenges can stall development, drain resources, and limit market opportunities.

Comprehensive Regulatory Writing & Publishing Solutions

We offer end-to-end regulatory writing and publishing solutions to support every stage of your product lifecycle:

Study-Related Documentation – Clinical trial protocols, study concept sheets, informed consent forms, statistical analysis plans, and clinical study reports.
Clinical Submission Writing – INDs, CTDs/eCTDs, integrated summaries of safety & efficacy, and regulatory correspondence.
Document-Level Publishing – PDF conversion, hyperlinking, compliance checks, and agency-ready formatting.
Safety Reports & Critical Documents – Investigator brochures, labeling, package inserts, and risk management documents.
Regulatory Consulting & Strategy – Submission planning, compliance guidance, and documentation workflows.

Our Expertise

Regulatory Compliance Mastery

Specialized Medical Writing Team

Tailored, Phase-Specific Solutions

Precision with Timely Delivery

What Our Clients Say

ADI’s professionalism, dedication to quality and exceptional work ethic drove the success of our partnership.

Karen Curie

Dear Maneet, I wanted to let you know how much I have enjoyed working with the ADI teams during the past ten and a half years. I am so impressed with the editors’ dedication and strong work ethic.

Andrea Bresnick

ADI has met all my company’s Medical Writing needs and their team has been a pleasure to work with. They respond to all inquiries in a timely manner and have never missed a deadline. They are very professional, and always deliver high quality writing.

Sara

From Data to Decisions, with Confidence

From INDs to NDAs and global CTD packages, QuantiNova is your trusted partner for accurate, compliant, and strategic regulatory writing. We don’t just prepare documents — we help bring your innovation to market faster, with the confidence that your submission speaks the language regulators expect.