Drug Patent Watch

JANUARY 14, 2025

In the fast-paced world of pharmaceuticals, negotiations play a pivotal role in shaping the industry’s landscape. Let’s dive into the intricacies of pharmaceutical negotiations, exploring valuable lessons, current trends, and strategies for success.

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Drug Patent Watch

MARCH 26, 2025

The Unseen Hurdles of Generic Drug Development: Lessons Learned As the pharmaceutical industry continues to evolve, one thing remains constant: the pursuit of affordable, high-quality medications for patients worldwide. This not only helps to ensure compliance, but also fosters a culture of trust and cooperation within the industry.

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thought leadership

JUNE 6, 2025

The journey from compound discovery to market-ready pharmaceutical product is long, complex, and resource-intensive. Medical Information (MI) services are instrumental Product Lifecycle Management (PLM) —ensuring safety, efficacy, and compliance while driving value and maintaining a patient-centric focus.

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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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thought leadership

AUGUST 10, 2023

Compliance auditing is a crucial process in the pharmaceutical industry, that helps ensure the safety, effectiveness, and high quality of pharmaceutical products and medical devices.

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Drug Patent Watch

MARCH 17, 2025

Unlock the Secrets to a Successful Generic Drug Launch Are you a pharmaceutical executive looking to bring a generic version of a popular medication to market? In today's highly competitive pharmaceutical industry, generic drug launches can be a game-changer for companies looking to increase market share and revenue.

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Drug Patent Watch

AUGUST 28, 2024

The European Union (EU) has implemented a robust regulatory framework to ensure the quality and safety of active pharmaceutical ingredients (APIs) used in medicines.

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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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DS in Pharmatics

MARCH 3, 2025

Qualified person (QP) certification and declaration are distinct in their objectives within pharmaceutical and biotech industries. Heres a quick overview: Together, these processes are essential for maintaining EU regulatory compliance, []

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The Pharma Data

JUNE 6, 2025

JCR Pharmaceuticals Celebrates 50 Years of Innovation with Global Website Launch That Reflects Its Expanding Reach and Human-Centric Mission As JCR Pharmaceuticals commemorates its 50th anniversary, the global specialty biopharmaceutical company is marking this major milestone with the launch of a newly designed global website.

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H1 Blog

NOVEMBER 15, 2023

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. However, with strict regulations surrounding interactions between industry and healthcare professionals, compliance must be at the forefront of any KOL engagement plan.

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Drug Patent Watch

DECEMBER 12, 2024

This approach not only helps maintain market exclusivity but also ensures a steady revenue stream for pharmaceutical companies. Understanding the Pharmaceutical Market Dynamics The pharmaceutical industry is a complex ecosystem where branded drugs and generics coexist, each playing a vital role in patient care and market dynamics.

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FDA Law Blog: Biosimilars

NOVEMBER 30, 2023

The 2023 Food and Drug Law Institute’s (“FDLI”) Enforcement, Litigation and Compliance Conference will boast two speakers from Hyman, Phelps & McNamara, P.C. (“HPM”), The conference will also include its annual panel discussion with FDA’s Center Compliance Directors. Blumberg Memorial Lecture. next week, on December 6-7, 2023.

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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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Drug Patent Watch

DECEMBER 11, 2024

Here are some key strategies to achieve operational excellence in a CDMO: Implementing Robust Controls Compliance with Regulatory Guidelines : Ensure compliance with strict regulatory standards set by global authorities such as the U.S.

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thought leadership

APRIL 10, 2025

Explore key steps to successfully enter the European pharmaceutical market, including navigating regulatory frameworks, ensuring quality compliance, and obtaining Wholesale Distribution Authorization.

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Drug Patent Watch

JANUARY 8, 2025

Drug patents are a form of intellectual property protection that grants pharmaceutical companies exclusive rights to manufacture, sell, and profit from their innovations for a set period. Types of Patents in the Pharmaceutical Industry Not all patents are created equal. Defending Your Patents Obtaining a patent is only half the battle.

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Drug Target Review

JUNE 6, 2025

GMP compliance is non-negotiable in this field. End-to-end development Unlike many organisations in the pharmaceutical sector, RadioMedix maintains an integrated model from pre-clinical development through to commercial manufacturing. These measures ensure both the efficacy and safety of the final product.

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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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thought leadership

SEPTEMBER 19, 2024

Welcome to the Diary of Compliance, where we follow the journey of Allison Audit, the dedicated and detail-oriented Quality Assurance Manager at Acme Pharma. Over the course of a year, Allison takes us through the highs and lows of ensuring her company meets the rigorous FDA CAPA (Corrective and Preventive Actions) requirements.

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Drug Patent Watch

MARCH 13, 2025

From manufacturing and quality control to distribution and regulatory compliance, the stakes are high for pharmaceutical companies looking to bring these life-changing treatments to market. One of the biggest hurdles biosimilar manufacturers face is the need to replicate complex biological processes with precision and consistency.

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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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thought leadership

MARCH 12, 2025

When a pharmaceutical company completes clinical trials and prepares to launch a medical product, the focus often shifts to regulatory approvals, market access, and commercialization.

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thought leadership

SEPTEMBER 2, 2024

Navigate the complexities of EU GMP compliance with ProPharma’s expert guidance. Learn essential strategies for ensuring quality and safety in pharmaceutical manufacturing.

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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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Advarra

DECEMBER 14, 2023

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. In addition, providing CROs and sponsors visibility to site training compliance allows them to provide additional support and mitigate risk if necessary.

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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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DS in Pharmatics

JANUARY 16, 2024

The pharmaceutical industry is growing through global collaboration and market expansion. To continue this growth, regulatory compliance for Chemistry, Manufacturing and Controls (CMC) must be followed. Without CMC regulatory compliance, the safety behind the creation of any products could be compromised.

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Drug Channels

APRIL 19, 2021

Informa Connect’s Compliance Congress for Specialty Products. June 22-24, 2021 | Virtual Event www.informaconnect.com/specialty-compliance/. Up your compliance game at this important event serving the unique sector of Specialty Products, the 7th annual Virtual Compliance Congress for Specialty Products.

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Advarra

DECEMBER 17, 2024

Continued harmonization will not only ease the regulatory burden but also facilitate faster study initiation and improve compliance. There are varied opinions about site consolidation, but I would like to add some perspective: Pharmaceutical companies routinely buy up small pharmaceutical and biotech companies and add them to their portfolio.

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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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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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Perficient: Drug Development

APRIL 17, 2025

O ur life sciences team is d e dicate d to supporting clients in the pharmaceutical, biotechnology, medical technology , and contract research organization sectors. As a result, we have d riv e n innovative growth for 14 of the 20 largest pharmaceutical and biotechnology companies , as well as 14 of the 20 largest medical device firms.

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Perficient: Drug Development

JANUARY 14, 2025

Kristen Quick, Director at Perficient, shared her insights on the transformative potential of Salesforce Life Sciences Cloud for pharmaceutical and med tech organizations, highlighting its ability to drive innovation and improve outcomes. Future Advancements and Innovations The power of Life Sciences Cloud is just beginning.

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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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Advarra

AUGUST 8, 2024

We also summarize the key information pharmaceutical companies and contract research organizations (CROs) need to know to prepare for compliance. While some of the AI Act’s compliance dates are set for August 2024, the full Act will be enforced in March 2026.

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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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