Regulatory Writing

From new moon to full moon—get expert support through every phase of regulatory writing.

In the world of Life Sciences, precision and clarity are non-negotiable. Whether your product is in early development or nearing launch, Alphanumeric's Regulatory Writing Services shine a light on your path to market. Just like the phases of the moon, each step in your regulatory process demands the right balance of compliance, clarity, and scientific insight.

Regulatory Writing Across Every Phase

Early Development Writing

Start your regulatory journey grounded in scientific integrity. Our expert writers—trained scientists with deep regulatory knowledge—ensure your foundational documents are clear, compliant, and submission-ready.

Key Services Include:

Protocols & Protocol Amendments
Investigator’s Brochures (IBs)
Informed Consent Forms (ICFs)
Preclinical Study Reports

Clinical Trial Support

As your clinical trials begin to take shape, our writers support your expanding documentation needs—ensuring quality, speed, and consistency across every document.

Key Services Include:

Clinical Study Reports (CSRs)
Safety Narratives
Development Safety Update Reports (DSURs)
Periodic Safety Update Reports (PSURs)

Regulatory Submissions

As your product advances, our writers guide your submissions with precision and clarity, ensuring consistency and compliance throughout the process.

Key Services Include:

INDs / NDAs / BLAs / MAAs
Module 2 Summaries (Quality, Nonclinical, Clinical)
Integrated Summaries of Efficacy and Safety (ISE/ISS)
Risk Management Plans (RMPs)
Briefing Documents for FDA/EMA Meetings

Post-Market Lifecycle Management

Even after market approval, regulatory needs persist. We support you in maintaining compliance and documenting updates with clarity and speed.

Key Services Include:

Annual Reports
Labeling Documentation
Variations and Amendments

Why Alphanumeric?

Accelerate Submissions: Our documents are designed to help you get to market—faster and smarter.
Scientifically Grounded: Writers with PhDs and industry training ensure precision and defensibility.
Globally Aligned, Locally Adapted: We tailor documents to meet region-specific submission requirements.
Cross-Functional Collaboration: Seamless integration with your clinical, safety, and regulatory teams.

Partnering with Alphanumeric Experts Drives Better Outcomes

100% compliance adherence rate to ICH, GCP, and region-specific formatting guidelines.

Experience across 15+ therapeutic areas, including oncology, rare diseases, and neurology.

25% faster than industry average for clinical study protocols and CSR submissions.

Regulatory Writing

From new moon to full moon—get expert support through every phase of regulatory writing.