Drug Patent Watch

DECEMBER 30, 2024

The regulatory environment in Japan for generic drug development is complex and has undergone significant changes in recent years. New Drug Application (NDA) : Needed for marketing approval of new drugs. Abbreviated New Drug Application (ANDA) : Required for marketing approval of generic drugs.

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Drug Development Clinical Pharmacology Clinical Trials Pharmaceutical Companies 52

Drug Patent Watch

DECEMBER 11, 2024

Your Drugs Development Stage The stage of your drug development is a critical factor in selecting a CDMO. Adhering to industry standards, a preference exists for utilizing the same CDMO for both development and commercial manufacturing to enhance communication and timeline management.

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Pharmaceutical Companies Pharmaceuticals Compliance Drug Development 96

Alta Sciences

FEBRUARY 19, 2025

Regulatory Guidance for Oligonucleotide Bioanalysis in Drug Development pmjackson Wed, 02/19/2025 - 21:30 The unique physicochemical properties of oligonucleotides require the use of specialized bioanalytical approaches, with key considerations including selectivity and specificity, sensitivity, stability, and matrix effects.

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Drug Development Clinical Pharmacology Immune Response Drugs 52

Drug Patent Watch

DECEMBER 10, 2024

Generic drug development is a complex process that involves not only scientific and medical expertise but also adherence to strict legal and ethical standards. Scientific expertise plays a crucial role in ensuring that generic drugs are held to the same standards of quality, safety, and efficacy as their brand-name counterparts.

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Drug Development Pharmacokinetics Compliance Drugs 95

Drug Patent Watch

DECEMBER 10, 2024

Here, we will explore how CDMOs can provide support in regulatory compliance, ensuring that products meet the strict demands of safety, purity, and efficacy. They can help ensure that these submissions are complete, accurate, and timely, which is critical for advancing drug development programs. Societal CDMO. link] LGM Pharma.

Compliance 96

Compliance Pharmaceuticals Pharmaceutical Companies Regulations 96

Perficient: Drug Development

NOVEMBER 14, 2023

Non-compliance with these regulations can result in hefty fines, as seen with Sephora’s recent $1.2 million penalty. The Growing Need for Consent Management The proliferation of privacy laws and regulations worldwide has led to a multitude of compliance deadlines.

Compliance 98

Compliance Regulations Production Marketing 98

Perficient: Drug Development

MARCH 27, 2025

Our Databricks Practice holds FinOps as a core architectural tenet, but sometimes compliance overrules cost savings. There is a catch once we consider data deletion within the context of regulatory compliance. However; in regulated industries, their default implementation may introduce compliance risks that must be addressed.

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Compliance Regulations Government International 64

Perficient: Drug Development

FEBRUARY 11, 2025

ADA Compliance Overview ADA compliance ensures websites are accessible to people with disabilities, promoting inclusivity and fairness. Ensuring clear focus visibility is key for accessibility; sometimes, visually impaired users and keyboard navigators have trouble interacting with web content. By following the WCAG 2.0

Compliance 52

Compliance Trials Marketing 52

Drug Target Review

JUNE 6, 2025

Image credit: Crystal Eye Media / Shutterstock The role of SPICA and manufacturing capabilities Drug development in the radiopharmaceutical space is particularly resource intensive. GMP compliance is non-negotiable in this field.

Therapies 100

Therapies Treatment Drug Development Clinical Development 100

ProRelix Research

MAY 10, 2025

Herbal clinical trials in […] The post Essential Compliance Checklist for Regulations on Herbal Clinical Trials in USA appeared first on ProRelix Research. With the increasing popularity of herbal products for both preventive care and therapeutic intervention, the demand for rigorous scientific validation is stronger than ever.

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Clinical Trials Compliance Regulations Trials 52

Perficient: Drug Development

MAY 22, 2025

Every blog post, product update, or social post is a potential compliance risk if not handled carefully. For many firms, keeping up with compliance while managing complex content workflows feels like juggling chainsaws. Legal, Compliance, Risk, and other teams are deeply involved in every asset. All tracked. All compliant.

Compliance 52

Compliance Marketing Government Production 52

Quanticate

APRIL 29, 2025

Clinical research is evolving as technology advancements enable more sophisticated drug development methods, dramatically increasing the speed, volume, and complexity of clinical trial data generation.

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Clinical Trials Drug Development Trials Compliance 59

Fierce BioTech

APRIL 28, 2025

Accelerating Time-to-Market: Balancing Speed, Compliance, and Operational Excellence jpiatt Mon, 04/28/2025 - 14:42 Tue, 06/24/2025 - 10:00 Resource Type Webinar Promotion Start Thu, 05/01/2025 - 08:30 Promotion End Sat, 11/01/2025 - 08:30 In the highly competitive world of drug development, few things matter more than getting to market first.

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Compliance Marketing Drug Development Regulations 52

DS in Pharmatics

APRIL 18, 2025

Discover the five pillars of drug development consulting: regulatory compliance, clinical trials, preclinical research, CMC, and market access.

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Drug Development Clinical Trials Compliance Drugs 52

Drug Target Review

APRIL 7, 2025

In a recent survey conducted by ICON, Plc, biomarker selection was identified by 35 percent of respondents as a top challenge among drug developers for phase I trials, second only to navigating regulatory compliance (- 38 percent). Silver Spring (MD): Food and Drug Administration (US); 2016-. 113:9861002.

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Clinical Development Clinical Trials Clinical Pharmacology Trials 69

Drug Patent Watch

DECEMBER 10, 2024

Generic drug development is a complex process that requires a deep understanding of regulatory requirements and guidelines. Regulatory expertise plays a crucial role in ensuring that generic drugs meet the necessary standards for quality, safety, and efficacy. ” Scientific Research Publishing , 2024. ” U.S.

Drug Development 52

Drug Development Compliance Drugs Regulations 52

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.

Compliance 52

Compliance Regulations Government International 52

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. Partner with us to ensure your medical device software meets the highest standards of accessibility and compliance.

Compliance 52

Compliance FDA Engineering Production 52

Perficient: Drug Development

APRIL 8, 2024

To bolster its capabilities and ensure compliance, the bank sought assistance from Perficient in delivering exceptional project and program management services to tackle their significant hurdles.

Compliance 52

Compliance Government International 52

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.

Compliance 52

Compliance International Regulations Marketing 52

FDA Law Blog: Drug Discovery

MAY 1, 2024

proudly announces the return of attorney Sarah Wicks to its drug development and compliance group. Sarah brings a wealth of experience and a proven track record of advising innovative drug and biologics companies through the intricate landscape of product development and commercialization.

Drug Development 52

Drug Development Molecular Biology Compliance Clinical Trials 52

Perficient: Drug Development

DECEMBER 18, 2023

In the fast-paced realm of finance, the significance of regulatory risk and compliance management practices cannot be overstated. The Role of Regulatory Risk and Compliance 1. Compliance with these legal obligations is not only mandated by regulatory authorities but also necessary for maintaining an institution’s reputation.

Regulations 111

Regulations Compliance 111

Perficient: Drug Development

NOVEMBER 20, 2024

Observe Develop a complete inventory of cryptographic assets from both a network and application perspective. Prioritize assets based on compliance requirements and risk levels. Analyze key exchange mechanisms like TLS and SSL to understand current vulnerabilities.

Government 106

Government Compliance Research 106

Perficient: Drug Development

MARCH 25, 2025

Look for folks who: Actually understand the data (a rare breed, cherish them) Can handle details without going cross-eyed Won’t melt down when stuck between the rock of compliance and the hard place of IT Bonus: Give them a fancy title like “Data Integrity Czar.”

Government 52

Government Compliance Regulations 52

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?

Compliance 52

Compliance Engineering Marketing 52

Drug Patent Watch

JANUARY 9, 2025

Navigating the complex landscape of drug development and manufacturing can be a daunting task. Enter the Contract Development and Manufacturing Organization (CDMO) a lifeline for many startups looking to bring their innovative therapies to market. How can you ensure your CDMO is up to scratch?

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Compliance Drug Development Pharma Companies Therapies 52

ACTO

DECEMBER 17, 2024

These councils bring together diverse expertise from scientists and researchers, data analysts and technology specialists, regulatory compliance experts, as well as commercial operations leaders. Such cross-functional collaboration ensures consistent implementation from drug development through commercialization.

Government 52

Government Compliance Pharmaceutical Companies Pharmaceuticals 52

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.

Compliance 52

Compliance Regulations Production Government 52

Perficient: Drug Development

OCTOBER 16, 2024

On the retention front, employee journey mapping can reveal pain points such as frustration with time-consuming compliance training. Some even provide ‘test-first’ options, allowing employees to bypass familiar material, focusing only on areas where they need development.

Compliance 105

Compliance Production Marketing Research 105

Perficient: Drug Development

MAY 14, 2025

Can you demonstrate robust security measures and regulatory compliance? Data security and compliance with regulations like HIPAA, GDPR, or PCI are likely critical requirements for your organization. Ask your vendor for clearly defined compliance certifications, and if they conduct regular security audits.

Compliance 52

Compliance Regulations Production 52

Perficient: Drug Development

AUGUST 4, 2024

Improved Security and Compliance With stringent regulatory requirements in the financial sector, security and compliance are paramount. Regulatory Reporting and Compliance Automation Compliance reporting is often a resource-intensive process.

Compliance 110

Compliance Marketing Production 110

Conversations in Drug Development Trends

JANUARY 6, 2025

End-to-end workflow automation, from sample receipt, processing, analysis, and reporting, will likely become an industry standard, making it an essential tool for drug development. Biomarkers are indispensable tools in clinical trials, providing critical insights that enhance the efficiency and precision of drug development.

Clinical Trials 52

Clinical Trials Trials Drug Development Therapies 52

PPD

JUNE 17, 2025

Biopharmaceutical and biotech drug developers have faced increasing challenges in recent years. In the past decade alone, the time needed to complete a clinical trial has increased by 20–30%, and the cost to bring a new drug to market has risen to an average of about $2.6

Clinical Development 52

Clinical Development International Drug Development Clinical Research 52

Perficient: Drug Development

JANUARY 6, 2025

Legal Compliance Many countries have regulations and laws that mandate accessibility in public services, including healthcare. Adopting braille and large print is not just a matter of best practice but also legal compliance, ensuring that healthcare providers meet the required standards for accessibility.

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Compliance Regulations Treatment Production 52

PPD

JULY 8, 2025

AI has applications from the simple to the complex; from automating mundane tasks and accelerating drug development, to increasing accuracy in documentation and uncovering complex correlations within vast datasets. Errors jeopardize patient safety, regulatory compliance and trust. But the stakes are uniquely high.

Clinical Research 52

Clinical Research Research Compliance Government 52

Drug Target Review

APRIL 30, 2025

The future of AI in CGT AI holds tremendous potential to reshape drug discovery and development in CGT. From precise target identification to optimised gene-editing techniques and streamlined clinical trial designs, AI has the capacity to transform every stage of the drug development pipeline.

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Drugs Therapies Clinical Trials Trials 90

PPD

JULY 29, 2024

In today’s data-driven world, AI has become valuable and indispensable, enabling organizations to extract valuable insights from vast amounts of data, make informed decisions and drive innovation across different sectors — including drug development.

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Clinical Research Clinical Trials Research Trials 98