Regulatory Sciences

Regulatory Sciences applies scientific principles to ensure products meet safety, efficacy, and compliance standards across global markets. This discipline plays a critical role in bringing new therapies to patients while adhering to evolving regulatory requirements. The blog posts below explore how regulatory science supports innovation and approval processes.

Regulatory Sciences

FDA Launches Crackdown on Deceptive Drug Advertising

On September 9, 2025, the US Department of Health and Human Services (HHS) and FDA unveiled a sweeping effort to clamp down on misleading direct-to-consumer (DTC) pharmaceutical advertising. The...

Regulatory Sciences

Transparency Requirements and the Requirement for Document Redaction

In an era of increasing scrutiny and demand for transparency in clinical research, the European Union (EU) has taken significant strides to enhance public access to clinical trial data and ensure the...

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Regulatory Sciences

FDA to Release CRLs in Real Time: What Does This Mean for Drug Developers?

On September 4, 2025, FDA announced a sweeping policy change: the real-time release of Complete Response Letters (CRLs); a continuation of FDA's July 10, 2025 publication of previously undisclosed...

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Regulatory Sciences

MAH Expertise Across Eastern Europe — and Beyond

Navigating pharmaceutical regulations across multiple countries isn't just about knowing the rules — it's about understanding the rhythm of each market, responding quickly to change, and having the...

Regulatory Sciences

MLR Submission Checklist: Preparing for Speed and Compliance

Pharmaceutical, biotech, and MedTech companies invest significant time and resources into developing promotional materials, only to face avoidable delays during the Medical, Legal, and Regulatory...

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Regulatory Sciences

Maximizing Clinical Trial Success: Strategic Approaches for Adding EU Member States in CTIS

Strategic Guidance for Expanding Clinical Trials Across EU Member States with CTIS Expanding a clinical trial to additional Member States within the European Union (EU) Clinical Trial Regulation...

Regulatory Sciences

FDA Inspection Readiness: Top Observations and How to Avoid a Form 483

For medical device manufacturers, FDA inspections are a critical component of regulatory oversight and quality assurance. Whether part of a routine surveillance program, pre-approval inspection, or...

Regulatory Sciences

The Moving Regulatory Landscape for Gene Therapy Trials in EU

Submitting a GMO Application for a Clinical Trial with AAV Viral Vectors Navigating the regulatory landscape for clinical trials in the European Union (EU) has become more streamlined with the...

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Regulatory Sciences

Omnichannel Marketing in Pharma: A Strategy Guide for Regulatory Compliance

As emerging marketing technologies rapidly evolve and reach maturity, marketers can now unlock sophisticated new tools to more efficiently and effectively reach consumers. As always, marketers remain...

Regulatory Sciences

Mastering Clinical Trial Submissions in Europe: A Guide for Drug Developers

Launching a clinical trial in Europe is a complex but rewarding endeavor, requiring careful navigation of regulatory frameworks, ethical requirements, and submission processes. Recent regulatory...

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Regulatory Sciences

CMC Expectations During Drug Substance Transfer from Ex-US Manufacturers

Regulatory Drivers for US-based API Manufacturers Recent shifts in US tariff policies have introduced new pressure points in the global pharmaceutical supply chain, particularly for manufacturers...

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Regulatory Sciences

Advancing Digital Transformation in Medicines: EMA's Successful ePI Pilot

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have recently concluded a successful pilot project on electronic product information (ePI), marking a significant...

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Regulatory Sciences

FDA's "Radical Transparency" Shift: What Regulatory Pros Need to Know

A New Era of FDA Disclosure On Thursday, July 10, 2025, FDA published more than 200 decision letters, known as complete response letters (CRLs). The CRLs were issued in response to applications...

Regulatory Sciences

Leveraging Online FDA Information to Accelerate ANDA Timelines

In the race to generic drug approval, timing is everything. Delays in Abbreviated New Drug Application (ANDA) submissions or setbacks during FDA review can mean missed market opportunities,...

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Regulatory Sciences

Maximizing the Value of FDA Pre-IND Meetings for Successful 505(b)(2) NDA Submissions

For drug developers leveraging the 505(b)(2) pathway, the FDA Pre-Investigational New Drug (Pre-IND) meeting is a strategic opportunity that can shape the trajectory of an entire development program....

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Regulatory Sciences

FDA's Commissioner’s National Priority Voucher (CNPV) Pilot Program Overview

An inside look at FDA's new Commissioner's National Priority Voucher (CNPV) pilot program—what it is, why it matters, and how regulatory and development teams can leverage it to accelerate...