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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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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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.

Drug Development 52

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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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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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Pharmaceuticals Regulations Government Production 52

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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Regulations Marketing Compliance Production 52

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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Production FDA Compliance Disease 52

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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Clinical Trials Regulations Compliance Government 98

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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Compliance FDA Clinical Trials Trials 52

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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Pharmaceuticals Regulations Compliance 52

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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Pharmaceuticals Compliance Regulations Production 52

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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Clinical Research Research Clinical Trials Bioethics 52

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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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.

Pharmaceutical Companies 59

Pharmaceutical Companies Compliance Pharmaceuticals Regulations 59

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.

Engineering 52

Engineering Production Compliance Laboratories 52

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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Compliance Pharmaceuticals Regulations Production 52

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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Compliance Laboratories Pharmaceuticals Regulations 52

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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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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Compliance Drugs Regulations Science 75

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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Compliance Regulations Pharmaceuticals 52

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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Compliance FDA Regulations Government 59

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.

Compliance 52

Compliance Regulations Production Pharmaceuticals 52

Agency IQ

MAY 3, 2024

What we expect European regulators to do in May 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Regulations Clinical Trials Production Biosimilars 40

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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Clinical Research Research Compliance Clinical Trials 52

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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Government Compliance Pharmaceutical Companies Pharmaceuticals 52

PPD

AUGUST 16, 2023

However, as the world settles into its post-pandemic state and returns to pre-pandemic paradigms in many areas, the pharmaceutical industry remains dedicated to moving beyond traditional, centralized clinical trial constructs. Fortunately, leading global regulators have launched key initiatives.

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Clinical Trials Trials Clinical Research FDA 98

Agency IQ

MARCH 7, 2024

British regulators tease new device regulations in informative live session This week, the British regulator MHRA offered a new peek into its planned medical device regulations. BY COREY JASEPH, MS, RAC | MAR 5, 2024 11:10 PM CST Quick background on medical device regulation in the U.K. post-market regulation here.]

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Drug Patent Watch

DECEMBER 10, 2024

These agencies set guidelines and regulations that generic drug manufacturers must follow to ensure that their products are bioequivalent to the innovator drug. Regulatory agencies also conduct inspections and audits to ensure compliance with Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) guidelines. ” U.S.

Drug Development 52

Drug Development Compliance Drugs Regulations 52

The Pharma Data

JANUARY 13, 2021

Avoid risking the quality of water in manufacturing practice, subsequent product process delays and compliance issues with this handy guidebook. 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.

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Compliance Regulations Production Pharmaceuticals 52

Fierce BioTech

APRIL 11, 2024

Benefits: Gain insights into GMP compliance, understand critical considerations for storage optimization, and learn about Alcami's unique capabilities. png Listing Introduction Discover the critical factors driving GMP compliance with five crucial considerations for pharmaceutical storage. Click here to login.

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Compliance Pharmaceuticals Regulations FDA 52

Agency IQ

MARCH 15, 2024

California publishes draft regulations for landmark plastic pollution reduction act CalRecycle has launched the formal rulemaking process for Senate Bill 54, which will implement a sweeping plan to reduce plastic waste in the state by 2032. However, a producer may also choose to apply for independent compliance with the requirements.

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ACTO

APRIL 28, 2023

The pharmaceutical industry is facing a critical challenge of unapproved content usage in the field, as revealed in a recent survey conducted by Citeline, that explored the prevalence and impact of this behavior. “Compliance starts with the sales force understanding its importance. Stay updated on regulations.

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Compliance Regulations Pharmaceuticals Production 52

Drug Channels

SEPTEMBER 16, 2024

The Patient Support Services Congress is designed to help educate and share innovative program design, latest customer strategies and practical solutions to overcome complex access barriers, enhance program performance and deliver best-in-class patient programs amidst evolving regulations.

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Compliance Regulations Pharmaceuticals Drugs 52

Fierce BioTech

JANUARY 19, 2024

Uncover the revolutionary role of video in transforming communication within the pharmaceutical industry and learn how to harness its power effectively. Join us to understand the impact of social video, from engaging healthcare professionals, patients, and caregivers to crafting a winning strategy that aligns with compliance standards.

Compliance 52

Compliance Pharmaceutical Companies Pharmaceuticals Regulations 52

ACTO

SEPTEMBER 26, 2023

Understanding the ROI Challenge in Pharma Training Before delving into the potential of personalized learning, it's crucial to understand pharmaceutical companies' challenges when measuring training ROI. Conclusion The pharmaceutical industry is complex, and sales representatives must stay ahead of the curve.

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