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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thought leadership

APRIL 14, 2025

Ensuring patient safety and compliance with pharmacovigilance (PV) regulations is a critical responsibility for marketing authorization holders (MAHs). A thorough understanding of these requirements can enhance operational efficiencies and reduce compliance costs for MAHs.

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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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thought leadership

OCTOBER 9, 2024

ProPharma wins CPHI Pharma Award for excellence in regulatory and compliance innovation, enhancing efficiency and accelerating market access for life-saving therapies.

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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. With trials facing a median delay of 12.2

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Drug Patent Watch

FEBRUARY 12, 2025

However, delays in any of these stages can significantly impact the overall timeline, leading to missed market opportunities and revenue losses. By implementing these strategies, generic drug manufacturers can accelerate their development timelines, improve efficiency, and increase their chances of success in the market.

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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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Perficient: Drug Development

MAY 30, 2024

Representatives from all three lines of defense—operational management, risk management/compliance, and internal audit—attend to present, discuss, and learn about industry shifts that are impacting risk and regulatory compliance. Sessions include a keynote interview with former FBI director James B.

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Perficient: Drug Development

MARCH 26, 2024

Accessibility compliance is crucial to providing equal access to all users, including those with disabilities. Importance of Accessibility Compliance Accessibility compliance ensures that websites are usable by individuals with disabilities, such as vision impairments, mobility issues, or cognitive challenges.

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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

AUGUST 28, 2024

The EU’s Good Manufacturing Practice (GMP) guidelines provide the minimum standards for API manufacturing, and compliance with these guidelines is mandatory for all manufacturers and importers of APIs intended for the EU market.

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Perficient: Drug Development

OCTOBER 9, 2024

Accessibility compliance in medical device software is more than a regulatory checkbox; it’s a strategic necessity that impacts user safety, market reach, and brand reputation. This not only fulfills moral, ethical, and regulatory obligations but also opens up new market opportunities. billion people with $1.9

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H1 Blog

NOVEMBER 15, 2023

However, with strict regulations surrounding interactions between industry and healthcare professionals, compliance must be at the forefront of any KOL engagement plan. In this blog post, we will explore why compliance is critical in medical affairs and how it can make or break successful KOL engagement strategies.

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Perficient: Drug Development

JUNE 25, 2024

ADA compliance ensures that your e-commerce site is usable by people with visual, auditory, and other impairments. Who needs to follow ADA compliance standards? Let’s have a deeper look at ADA compliance and what it means for eCommerce stores. Look for themes that explicitly mention ADA compliance. What is WCAG?

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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. New Drug Application (NDA) : Needed for marketing approval of new drugs.

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Fierce BioTech

MAY 7, 2024

Trust Transformed: Pharma Marketing in the Post-Cookie Era dwunderlin Tue, 05/07/2024 - 13:29 Tue, 06/11/2024 - 14:00 Resource Type Webinar David Minkin Clifton Covey Sonia V Gupta Duration 60 Minutes In the backdrop of digital advertising for pharmaceuticals we are undergoing a radical transformation as privacy becomes a paramount concern.

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FDA Law Blog: Biosimilars

SEPTEMBER 26, 2023

(HP&M), a leader in providing legal and regulatory support to the life sciences industries, today announced the appointment of Jeff Grizzel to the newly created position of Chief Marketing Officer (CMO). Jeff joins HP&M from Compliance Architects where he served as Vice President of Business Development.

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Perficient: Drug Development

FEBRUARY 12, 2025

This transformation will require a delicate balance between innovation and compliance, ensuring that advancements in AI contribute to a secure and efficient payments landscape. These changes require significant adjustments in risk management, compliance frameworks, and operational protocols.

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Perficient: Drug Development

AUGUST 4, 2024

Azure Integration Services provide the scalability required to handle varying workloads, ensuring businesses adapt quickly to changing market conditions without compromising performance. Improved Security and Compliance With stringent regulatory requirements in the financial sector, security and compliance are paramount.

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Perficient: Drug Development

SEPTEMBER 6, 2024

Salesforce’s position as a leader in this report reflects its current offerings, robust strategy, and strong market influence. Strategy: Forrester evaluates the vendor’s long-term vision, innovation roadmap, and ability to address future market needs.

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FDA Law Blog: Biosimilars

JUNE 10, 2024

It is critical that this guidance be reviewed in tandem with the guidance set forth in FDA’s Investigations Operations Manual (IOM) and the Regulatory Procedures Manual (RPM) , both of which provide more detail about how FDA investigators conduct investigations and make decisions about a firm’s regulatory compliance.

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Fierce BioTech

FEBRUARY 12, 2025

Listing Image Adragos-Logo-Listing.png Listing Introduction Expanding into Japan can be complex, but with the right expertise and regulatory knowledge, your products can successfully enter this high-potential market. Register now to secure your spot. On Demand Start Date Wed, 04/09/2025 - 11:00 End Date/Time Wed, 04/09/2025 - 11:00

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FDA Law Blog: Drug Discovery

MARCH 3, 2025

The conference will bring together industry leaders to explore evolving market trends, regulatory frameworks, and intellectual property strategies shaping the future of advanced therapeutics. Conference co-chairs include Derek Johnson (Managing Director and General Counsel, Portal Innovations) and Lulu Wang (Head of IP, Orna Therapeutics).

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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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Perficient: Drug Development

APRIL 17, 2025

. – Gina Hart, Managing Director, Dallas READ MORE: Delighting the Client Perficients Cross-Industry Expertise Empowers Businesses with Agile Strategies Our client-first approach and pragmati sm enable businessesto act swift ly and maintain a competitive edge in a rapidly evolving market.

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ASPET

AUGUST 21, 2024

Those models along with the surrogate markers can play important roles in quantifying TdP risk of new compounds, impacting late-phase clinical design and regulatory decision-making, and preventing adverse events on post-marketing clinical use.

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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. The goal of ICPs is to improve the quality of life for patients suffering from chronic respiratory diseases.

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Perficient: Drug Development

JULY 5, 2023

Salesforce Marketing Cloud (SFMC) enables you to deliver relevant, personalized journeys across channels and devices, enabling your marketing team to deliver the right messages to your customers at the right time. Please note, Data Cloud currently only supports Marketing Cloud Enterprise 2.0

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FDA Law Blog: Biosimilars

NOVEMBER 6, 2023

In response, we learned that only about seven – and certainly less than 10 – RIEs for manufacturing compliance have been performed at drug facilities in the last 30 months. The current and earlier guidances note that declining an RIE may delay regulatory decisions, such as approvals of applications for marketing authorization.

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thought leadership

SEPTEMBER 5, 2024

The real challenge begins post-approval, where careful management of your PMA is crucial to ensure ongoing compliance, maintain market access, and safeguard your product's reputation. But the journey doesn't end there.

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Perficient: Drug Development

MARCH 12, 2024

Embracing Regulatory Compliance with HIPAA Sitecore’s commitment to regulatory compliance, especially concerning HIPAA, further strengthens its position in the healthcare sector. Sitecore excels in this area, leveraging its technology to deliver personalized care that is both respectful and impactful.

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Perficient: Drug Development

FEBRUARY 27, 2025

For starters, savvy brands recognize a largely untapped market segment consumers with disabilities and consumers over the age of 65. Those Guidelines will be technically sound and used by practitioners across the globe, minimizing risk of non-compliance. Quite the contrary.

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Perficient: Drug Development

JANUARY 19, 2024

The container technology also supports varying levels of technical acumen, business continuity, security, and compliance. While offering flexibility, it comes with potential downsides such as slower time to market, increased operational costs, and higher risk due to the intricacies of self-managing containerized environments.

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Perficient: Drug Development

AUGUST 19, 2024

I have even heard the phrase “Please check the report, I don’t understand the models and hence trust the number” So, in the risk function, while this is a race for data aggregation, structured data, unstructured data, data quality, data granularity, news feeds, market overviews, its also a challenge from an acceptance perspective.

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Fierce BioTech

SEPTEMBER 29, 2023

From compliance and the cloud to AI and digitalization, this session will provide actionable insights and success stories that inspire you to leverage technology for your organization's benefit. Join us for a firsthand look at these real-world applications of technology in the life sciences industry.

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Drug Patent Watch

JANUARY 9, 2025

Enter the Contract Development and Manufacturing Organization (CDMO) a lifeline for many startups looking to bring their innovative therapies to market. In 2017, small and medium-sized biotech companies accounted for 51% of FDA market approvals, while large pharma companies were the originators in only 28% of approvals[4].

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Perficient: Drug Development

FEBRUARY 26, 2025

This series of blog posts will cover main areas of activity for your marketing, product and UX teams in advance of, during and after site migration to a new digital experience platform. From business goals and priorities, page views, conversion rate, SEO considerations and marketing campaigns, to compliance and regulations.

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