Drug Target Review

JULY 1, 2025

Regulatory backing The pharmaceutical industry is often open to innovation in principle, but the demands of regulatory compliance can slow the adoption of emerging technologies – particularly those that challenge conventional trial design. Unlearn’s early collaboration with regulators has helped it navigate this space effectively.

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Drug Patent Watch

DECEMBER 30, 2024

This article aims to provide a comprehensive overview of the key aspects of the regulatory framework, highlighting the requirements and challenges faced by pharmaceutical companies seeking to introduce generic drugs into the Japanese market. Retrieved from [link] Japan Pharmaceutical Manufacturers Association. Freyr Solutions.

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ACTO

DECEMBER 17, 2024

The stakes for AI adoption in the pharmaceutical industry have never been higher. Yet, the critical question remains: How can pharmaceutical companies ensure responsible and compliant AI implementation while maximizing its potential for field teams? This approach provides better control over data access and security.

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Advarra

DECEMBER 17, 2024

As the harmonization effort advances, the focus will likely shift toward refining guidelines and regulations for vulnerable populations, including children, pregnant women, and prisoners. Continued harmonization will not only ease the regulatory burden but also facilitate faster study initiation and improve compliance.

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Drug Patent Watch

FEBRUARY 12, 2025

Accelerating Generic Drug Development: Strategies for Success As a pharmaceutical professional, you know how crucial it is to navigate the complex landscape of generic drug development.

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Drug Patent Watch

MARCH 24, 2025

Navigating the Complex World of CDMO Contracts: What to Look Out For As a pharmaceutical professional, you're likely no stranger to the importance of finding the right Contract Development and Manufacturing Organization (CDMO) partner. Regulatory Compliance Regulatory compliance is a top priority in the pharmaceutical industry.

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H1 Blog

NOVEMBER 15, 2023

But in today’s highly regulated environment, it is more important than ever to make sure that HCP engagement plans are compliant with anti-kickback laws. Since KOLs play such a critical role, engaging with the right KOLs is a key strategy for pharmaceutical companies to stay ahead of the game.

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Drug Patent Watch

FEBRUARY 19, 2025

The Unsung Heroes of Generic Drugs: The Importance of Quality Assurance As we navigate the complex world of pharmaceuticals, it's easy to overlook the behind-the-scenes efforts that ensure the quality and safety of the medications we rely on. But what exactly does Quality Assurance entail?

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ProRelix Research

APRIL 17, 2025

Indiaprovidesanidealsettingforsuchcost-savingstrategiesduetoseveralkeyfactors: Economic Benefits Conducting trials in India can reduce costs by up to 60%comparedtoWesterncountries.Labor costs,participantrecruitment,hospitalinfrastructure,andadministrativefeesaresignificantly lower. […] The post Outsourcing Clinical Trials to India: Global Regulation, (..)

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PPD

DECEMBER 16, 2024

Addressing these underlying factors is essential; only by tackling the complexities of recruitment, timelines and regulatory compliance can sponsors achieve cost-effective and efficient trials, paving the way for long-term success in todays demanding market.

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Drug Patent Watch

FEBRUARY 20, 2025

The Unseen Heroes of the Pharmaceutical Industry: Achieving High-Quality Standards in Generic Drugs As we navigate the complex world of healthcare, it's easy to overlook the unsung heroes who work tirelessly behind the scenes to bring affordable, high-quality medications to the masses.

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Advarra

AUGUST 8, 2024

Artificial intelligence (AI) has taken the world by storm – and regulators are paying attention. We also summarize the key information pharmaceutical companies and contract research organizations (CROs) need to know to prepare for compliance. a synthetic control arm)?

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Fierce BioTech

FEBRUARY 12, 2025

Join us for an exclusive webinar where well guide you through the essential steps of meeting Japans regulations and strict quality requirement. Join us for an exclusive webinar where well guide you through the essential steps of meeting Japans regulations and strict quality requirement.

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The Premier Consulting Blog

NOVEMBER 6, 2024

Improved convenience and patient compliance: ICPs can offer improved convenience for patients by requiring only one device, rather than two or more separate inhalers – ultimately resulting in better patient compliance. However, these products present unique challenges from a Chemistry, Manufacturing, and Controls (CMC) standpoint.

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DrugBank

APRIL 25, 2024

As the pharmaceutical industry is pushing to deliver new and better drugs while racing against time and budget constraints, it is becoming crucial to not just use artificial intelligence (AI) but truly maximize its potential. Invest in Your Tech Infrastructure A solid tech foundation is essential for AI to work in the pharmaceutical sector.

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Advarra

DECEMBER 14, 2023

b)) Categorized within the investigational plan regulations, there is a specific emphasis on accurate and complete documentation of all trial activities. This enables higher levels of training compliance over the course of study conduct, as well as the necessary understanding of trial activities to perform the right task at the right time.

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thought leadership

APRIL 4, 2025

Pharmaceutical tariffs of 25% have been forecasted causing many global organizations to investigate the consequences of the tariffs on their overall product portfolio. The US Government recently modified their policy to utilize tariffs to in an effort to support the US economy.

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The Premier Consulting Blog

DECEMBER 10, 2024

Key components of the CMC section The CMC section of an NDA contains detailed information on the following aspects of the investigational drug: Drug substance or active pharmaceutical ingredient (API). Compliance with good manufacturing practices (GMP). Complying with global regulations. Managing risk is critical.

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The Pharma Data

JUNE 6, 2025

Global Pharmaceutical Contract Sales Outsourcing Market to Reach $24.8 Billion by 2030: Strategic Insights, Regional Trends, and Technological Shifts Reshaping the Landscape The global pharmaceutical contract sales outsourcing (CSO) market is entering a transformative phase, with its value expected to grow from $17.3

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thought leadership

SEPTEMBER 9, 2024

On April 26, 2023 the Commission adopted a proposal for a new Directive and a new Regulation which revise and replace the existing general pharmaceutical legislation under the following documentation.

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DS in Pharmatics

JULY 7, 2023

As a supply chain expert in the biotech and pharmaceutical industry, I understand the unique challenges faced by companies operating in this highly regulated and complex sector.

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Advarra

MARCH 6, 2025

Over the years, Advarra has reviewed a wide range of clinical research studies and worked every day alongside leading pharmaceutical manufacturers, medical researchers, and healthcare institutions. Industry-Leading Ethical Standards Advarra is organized and operates in compliance with U.S.

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Drug Patent Watch

JANUARY 9, 2025

The pharmaceutical landscape is evolving rapidly, with small and medium-sized biotech companies increasingly taking center stage in innovation. Managing Quality and Compliance Quality and regulatory compliance are non-negotiable in pharmaceutical manufacturing. How can you ensure your CDMO is up to scratch?

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The Pharma Data

JUNE 24, 2025

By combining USP’s rigorously characterized reference materials with Bio-Techne’s user-friendly, high-resolution analytical instruments, the collaboration intends to streamline workflows, improve data accuracy, and enable greater compliance with global regulatory expectations. Senior Vice President of Global Biologics at USP. Source link

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Drug Target Review

JULY 7, 2025

2 This ethical spotlight has practical implications for research institutions and sponsors, including the need for more robust justification protocols, heightened compliance measures and increased risk of reputational harm or funding loss. iPSC-cardiomyocytes in the preclinical prediction of candidate pharmaceutical toxicity.

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Alta Sciences

NOVEMBER 4, 2024

Case Study: How to Ensure Safety While Manufacturing Highly Potent APIs aasimakopoulos Mon, 11/04/2024 - 17:37 Highly potent active pharmaceutical ingredients (API) require careful attention to safety and handling during formulation and manufacturing.

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FDA Law Blog: Biosimilars

DECEMBER 4, 2023

Federal Court Orders Puerto Rico Pharmaceutical Distributor to Pay $12 Million in Connection with Alleged Failure to Report Suspicious Orders of Pharmaceutical Drugs and Other Controlled Substance Violations, Nov. 6, 2023 ( DOJ Press Release ). Consent Agreement and Final Judgment ¶ 10.a.-n.

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Fierce BioTech

JULY 15, 2024

Nitrosamines in Focus: Regulatory Requirements and Best Practices dwunderlin Mon, 07/15/2024 - 11:10 Thu, 09/12/2024 - 10:00 Resource Type Webinar Chris Williams Chad Bastian Duration 60 Minutes Nitrosamines, potent carcinogens, have prompted stringent regulations for their detection and control in various products. Click here to login.

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Drug Channels

SEPTEMBER 13, 2021

Thought-leaders and colleagues from federal agencies, bio/pharma manufacturers, consultants, industry trade associations and law firms will gather to discuss key insights on how current and future drug pricing transparency regulations will impact commercialization, reimbursement, pricing and compliance practices.

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FDA Law Blog: Biosimilars

JANUARY 4, 2024

The American Conference Institute (“ACI”) will be hosting the go-to forum for critical updates on OTC regulation and enforcement, monograph reform, ACNU and advertising essentials… and FDA Law Blog readers can get a discount. Deb along with fellow panelists Kyle Y.

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thought leadership

OCTOBER 23, 2023

In today's highly regulated pharmaceutical, biotechnology, and healthcare industries, maintaining compliance with GxP Practices , and other regulatory requirements is paramount.

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thought leadership

MAY 8, 2024

How ProPharma Can Help You Ensure Compliance with the New HTAR Requirements The new Health Technology Assessment Regulation (HTAR) will set new requirements for pharmaceutical companies seeking registration and market access in the European Union (EU) for their products.

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thought leadership

MAY 3, 2024

In the highly regulated pharmaceutical industry, ensuring the safety, quality, and efficacy of medicinal products is paramount. Particularly, within the European Union (EU) and the United Kingdom (UK), QP audits play a pivotal role in maintaining compliance with stringent regulatory standards.

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FDA Law Blog: Drug Discovery

MARCH 6, 2024

Claud will be featured at the Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products in New York, NY. Prior to HP&M, John served 15 years at the Department of Justice, serving most recently as the Assistant Director of the Consumer Protection Branch, where he led the Corporate Compliance and Policy Unit.

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FDA Law Blog: Biosimilars

MARCH 4, 2024

Walsh will contribute her extensive expertise in FDA regulatory matters to a session titled “Global Ad Promo and Enforcement Insights,” addressing the complex landscape of advertising and promotion compliance on a global scale. Attendees can expect to gain practical strategies for compliance and enforcement, drawn from Ms.

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The Pharma Data

JANUARY 6, 2021

Discover five good manufacturing practices for water monitoring and sanitization for pharmaceutical use. The control of water quality throughout the manufacturing lifecycle of a product, including storage and distribution, is a major focus for compliance regulators. Add bookmark. Download Your Copy.

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Advarra

SEPTEMBER 14, 2023

In the clinical research space, GxP is a set of quality regulations and guidelines designed to establish the safety, efficacy, and integrity of pharmaceuticals, medical devices, and clinical trials. This blog explores key concepts, regulations, and the importance of GxP in delivering successful clinical trials.

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